MY NAME IS PATRICIA HAGERTY THE ACTING DIRECTOR OF THE EXTRAMURAL ACTIVITIES PROGRAM. THE SESSION TODAY IS ABOUT THE OFFICE OF DIETARY SUPPLEMENTS INITIATIVES TO COORDINATE A CATALOG OF RESEARCH OVER THE PAST 25 YEARS. SO TO KICK US OFF I'LL TURN IT OVER IT MY COLLEAGUE, DR. ANNE THURN DIRECTOR OF THE ODS COMMUNICATIONS PROGRAM. SHE'LL INTRODUCE THE EVIDENCE-BASED RE VIEW PROGRAM. GO AHEAD, ANNE. YESTERDAY YOU HEARD A LITTLE BIT ABOUT THE ODS EVIDENCE-BASED REVIEW PROGRAM. I'M GOING GIVE YOU A VERY BRIEF DESCRIPTION OF IT. IN 2001 THERE WAS A MANDATE TO REVIEW THE EFFICACY AND SAFETY OF DIETARY SUPPLEMENTS INTO A DATA FIND RESEARCH NEEDS. ODS RESPONDED BY DEVELOPING AN EVIDENCE-BASED REVIEW PROGRAM WITH THE EVIDENCE-BASED PRACTICE CENTER PROGRAM THAT WAS ESTABLISHED BY THE AHRQ TO CONDUCT SCIENTIFIC REVIEWS AND TO PREPARE REPORTS. AND THERE'S PUBLISH AND UNPUBLISHED DATA AND TRANSLATIONS AS NEEDED RESULTING IN INDEPENDENT REVIEWS OF THE CURRENT STATE OF THE SCIENCE FOR A PARTICULAR TOPIC. OVER THE COURSE OF MORE THAN A DECADE, ODS COLLABORATED WITH OTHER NIH OFFICES, CENTERS AND INSTITUTES USING THE AHRQ PROGRAM TO ENSURE ALL EVIDENCE WERE CONSIDERED TO IDENTIFY AND PRIORITIZE RESEARCH ON DIETARY SUPPLEMENTS WITH POTENTIAL HEALTH BENEFITS OR SAFETY ISSUES. ALL OF WHICH HAVE PROVIDED GUIDANCE FOR THE DEVELOPMENT OF NIH RESEARCH AGENDAS. THIS IS THE LIST OF THE ODS-SPONSORED EVIDENCE REPORTS AND HAVE SERVED AS THE BASIS FOR PIER REVIEWED LITERATURE AND PROVIDE ASSESSMENT WHATEVER IS AND NOT KNOWN ABOUT A PARTICULAR TOPIC. PEER-REVIEWED LITERATURE. FOR PROVIDE STRONG SCIENTIFIC BASIS FOR FUTURE RESEARCH PLANNING. I'M GOING TURN THIS OVER TO DR. PATSY BRANNON FROM THE DIVISION OF NUTRITIONAL SCIENCE AT CORNELL. BESIDES HER EX TENSE BIBO, HE'S WORKED SHE'S WORKED ON THE VITAMIN D INITIATIVE AND IRON SUPPLEMENTATION AND PREGNANCY PROJECT. DR. BRANNON. >> THANK YOU, ANNE. I APPRECIATED THE INVITATION TO JOIN YOU TODAY AND AS YOU'VE HEARD AND PART OF MY DISCLOSURES I WAS A VISITING SCIENTIST IN THE OFFICE TWICE ON TWO DIFFERENT PROJECTS AND SO I'M GOING TO SPEAK TODAY AS BOTH AN ALUMNA OF ODS AND ALSO I WAS A MEMBER OF TWO DRI COMMITTEES, ONE ON SODIUM AND POTASSIUM RECENTLY AND THE OTHER ON CALCIUM AND VITAMIN D IN 2009 AND 2011 AND A MEMBER OF THE TECHNICAL EXPERT PANEL FOR ONE OF THE REVIEWS FOR THE VITAMIN D AND CALCIUM DRIs AND CURRENTLY A MEMBER OF THE FOOD SAFETY AND ADVISORY COUNCIL. I'D LIKE TO THINK ABOUT THE IMPACT OF THE EVIDENCE-BASED REVIEW PROGRAM IN TERMS OF EVIDENCE-BASED REPORTS AND RESEARCH AND I WANT TO CONSIDER A BROADER IMPACT ON NUTRITION AND EVIDENCE-BASED DECISION MAKING. AND I'M GOING TO TALK A LITTLE BIT ABOUT SYNTHESIS IN THE FIELD OF NUTRITION AND SPEAK ABOUT APPLICATION OF EVIDENCE SYNTHESIS TO DECISION MAKE LOOKING FIRST AT THE DIETARY REFERENCE INTAKES AND THEN PERHAPS SOME WILL THINK BEYOND THE EVIDENCE-BASED PROGRAM, I THINK I DO, IN TERMS OF CONSIDERATIONS OF DISEASE END POINTS FOR DIETARY REFERENCE INTAKES AND I'M GOING TO CONCLUDE WITH FINAL REFLECTION ARE MY OWN. I WANT, HOWEVER, TO BEGIN WITH THE CONTEXT. THE CONGRESSIONAL MANDATE CAME IN 2001. THIS IS A GRAPH OF ANNUAL PUBLICATIONS OF SYSTEMATIC REVIEWS OF MICRONUTRIENTS AND HEALTH. THERE ARE RELATIVELY A FEW PUBLISHED ANNUALLY PRIOR TO 2002. BY 2002, 2003 WHEN THE PROGRAM WAS UNDERWAY THERE WERE 14 SUCH PUBLISHED REVIEWS AND THAT'S GROWN AND TO GIVE YOU TODAY'S CURRENT CONTEXT BETWEEN 200 AND 300 SYSTEMATIC REVIEWS ON HEALTH OUTCOMES AND THIS IS A FIELD IN WHICH ODS CAME EARLY AS IT GREW IN THE FIELD OF NUTRITION. WHAT I WANT TO DO IS TAKE A LOOK AT THE EVIDENCE-BASED REPORTS AND SUBSEQUENT ACTIONS THAT RESULTED FROM THOSE REPORTS. AND THIS IS MY PERSPECTIVE. I WILL TELL YOU THAT NOW. SO THE FIRST OF THE REPORTS WAS A FEDERAL OF WHICH YOU HEARD FROM DR. COTES YESTERDAY PUBLISHED IN 2003 AND NOTED IT INFORMED THE DECISION THAT FDA MADE TO BAN EPHEDRA. THE NEXT SERIES OF REPORTS WERE ON OMEGA 3 FATTY ACIDS AND A VARIETY OF HEALTH OUTCOMES PUBLISHED BETWEEN 2004 AND 2005 AND A NUMBER OF ASSOCIATED PUBLICATIONS RESULTED AND TWO SUBSEQUENT ACTION INFORMED BY THIS SERIES OF EVIDENCE-BASED REVIEWS. THE FIRST WAS AN NIH, NHLBI WORKING GROUP THAT LOOKED AT DIRECTION ON OMEGA 3 FATTY ACIDS AND CARDIOVASCULAR DISEASE AND THE SECOND WAS A WORKSHOP ON OMEGA 3 FATTY ACID IN CARDIAC ARRHYTHMIC GENESIS AND THESE KINDS OF WORKSHOPS AFTER THE EVIDENCE-BASED REVIEWS EXEMPLIFY WHAT ANNE SPOKE UP IN TERMS OF THE IMPACT IN HELPING FIND RESEARCH NEEDS AND KNOWLEDGE GAPS. THE EVIDENCE-BASED REVIEW ON SOY RESULTS IN A WORKSHOP ON SOY PROTEINS AND ISOFLAVONES IN 2009. AND B VITAMINS AND BERRIES AND INFLAMMATION INFORMED THE STATE OF THE SCIENCE CONFERENCE IN 2006 THAT RESULTED IN A CONSENSUS STATEMENT. PROBIOTICS IS AN INTERESTING ONE AND COME BACK TO ACTIONS ON THAT ONE IN A MOMENT AND THEN THERE WAS A SERIES ON VITAMIN D. FIRST ON BONE HEALTH PUBLISHED IN 2007 AND WITH CALCIUM ON HEALTH OUTCOMES IN 2009 AND THEN AN UPDATE IN 2014. AND THIS SERIES OF EVIDENCE-BASED REVIEWS SPARKED A NUMBER OF ACTS INCLUDING A NUMBER OF WORKSHOP SIMYMPOSIUM AIMING TO FIND RESOURCES NEEDED AND THIS INCLUDED WORKSHOP AND A ROUNDTABLE IN 2007 FOLLOWED BY ANOTHER WORKSHOP ON THE NEEDS FOR TOOLS FOR RESEARCHERS IN 2008. A THIRD WORKSHOP ON BIOMARKER METHODS IN 2009. THE FIRST WORKSHOP OF THE VITAMIN D STANDARDIZATION PROGRAM YOU'LL HEAR ABOUT LATER IN 2013 AND A FINAL WORKSHOP THAT OCCURRED IN 2014 ON VITAMIN D MOVING TOWARDS EVIDENCE-BASED DECISION MAKE IN PRIMARY CARE. THE SERIES OF WORK SHOPS OF EVIDENCE-BASED REVIEWS IN 2007 AND 2009 ALSO INFORMED THE I.O.N.'S REVIEW OF CALCIUM. WHAT'S INTERESTING ABOUT PROBIOTICS AND TO SOME EXTENT THE FIRST VITAMIN D EVIDENCE BASED REVIEW BOTH WERE PRECEDED BY WORKSHOPS THAT THEN OBVIOUSLY SPARK THE EVIDENCE-BASED REVIEW. I THINK THAT'S INTERESTING TO NOTE IDENTIFYING CONTROVERSIES AND GAPS IN THE EVIDENCE CAN BE STIMULATE AN EVIDENCE-BASED REPORT AND ALSO STIMULATED BY EXPERTS GATHERING TOGETHER IN A WORKSHOP. YOU'LL HEAR A LOT ABOUT THE VITAMIN D WORKSHOP. I WANT TO GIVE YOU PERSPECTIVE HOW THE EVIDENCE-BASED REPORTS NOT SOLELY BY THEMSELVES BUT IN COMBINATION WITH ONGOING PROGRAMS AND OTHER EFFORTS AT ODS RESULTED IN A COORDINATED SET OF ANG -- ACTIONS STIMULATED BY THE REPORT. FIRST EVIDENCE-BASED REPORT WAS PRECEDE A CONFERENCE. THE EVIDENCE-BASED REPORTS WERE USED FOR IDENTIFYING KNOWLEDGE GAPS AND RESEARCH NEEDS AND THEY ALSO WERE INVALUABLE IN IDENTIFYING RESEARCH RESOURCES AND MATERIALS THAT WERE NEEDED IN ADDRESSING POPULATION STATUS AND THE NEED TO BE MEASURING AND THE HYDROXY G AND INFORMED THE DRI REVIEW IN AND 2011. WHAT'S IMPORTANT TO REMEMBER SAUL THE INTERACTIONS AND THE KNOWLEDGE GAPS AND RESEARCH RESOURCES AND MATERIALS IN THE POPULATION STATUS ISSUES ALL INTERACTED WITH EACH OTHER. SO I THINK THAT VITAMIN D INITIATIVE IS A VERY INTERESTING EXAMPLE OF ACTIONS ODS ENGAGED IN STEMMING FROM AN EARLY CONGRESSIONAL MANDATE IN 2001 AND THE FOCUS ON HEALTH NUTRITION PRIORITY. THE NEXT THING I WANT TO TALK ABOUT BRIEFLY IS THE IMPACT ON THE FIELD IN TERMS OF NUTRITION AND EVIDENCE-BASED SYNTHESIS. ODS'S EVIDENCE-BASED REVIEW PROGRAM IS CRITICAL ANALYSIS OF SYNTHESIS IN NUTRITION. IT'S NOT WITHOUT ITS CONTROVERSY NOW BUT AT THE TIME THE PROGRAMS STARTED IN 2001 AND 2003 SYSTEMATIC REVIEWS WERE CONTROVERSIAL AND WERE USED IN PHARMACEUTICAL SETTING AND SOME ASPECTS OF MEDICINE AND THERE WAS AND REMAINS TO SOME EXTENT THOSE WHO SAY THIS IS NOT FULLY APPROPRIATE TO APPLY TO NUTRITION. ODS TOOK ON THE CHARGE AND ISSUES AND WITH THE PARTNERSHIPS WITH ARHQ AND OTHERS DEVELOPED TECHNICAL REPORTS THAT ADDRESSED ISSUES OF IDENTIFYING THE CHALLENGES AND ADVANTAGES AND LIMITATIONS OF CONDUCTING NUTRITION-BASED SYSTEMIC REVIEWS AND WORKING WITH EXPERTS TO EXPLORE APPROACHES FOR INTEGRATING REVIEWS AND RELATED TO DECISION MAKE OF CRITICALLY EXPLORING THE CONSISTENCIES AND INCONSISTENCIES AND ADDRESSING THE BREADTH AND QUALITY OF CURRENTLY AVAILABLE SYSTEMIC REVIEWS RELATIVE TO GENERALLY ACCEPTED QUALITY GUIDELINES. AND THE CONTEXT WITHIN WHICH THE STUDIES OCCURRED IS EARLY WHEN SYSTEMIC REVIEWS WERE NOT AS PREVALENT BUT WHEN THE QUALITY OF SYSTEMATIC REVIEWS WAS EVEN MORE VARIABLE THAN PERHAPS IT IS TODAY. SO THE EFFORT TO DEVELOP AND SUPPORT CRITICAL APPROACHES TO EVIDENCE IN NUTRITION REALLY PLAYED A MAJOR ROLE IN THE GROWTH OF THE USE OF SYSTEMIC REVIEWS AND THE QUALITY OF SYSTEMIC REVIEWS. IN ADDITION TO THAT, ODS SUPPORTED RESEARCH ON AFFECTIVE APPROACHES FOR WHEN TO UPDATE SYSTEMIC REVIEWS AND I'M GOING TO TALK ABOUT THAT IN A * *. SO THE SERIES OF NUTRITION TECHNICAL RESEARCH REPORTS RESULTED IN A NUMBER THAT ADDRESSED ISSUES RELATED TO APPLYING SYSTEMIC REVIEWS IN NUTRITION. ISSUES RELATED TO REPORTING OF SYSTEMIC REVIEW OF MACRO NUTRIENT AND HEALTH. FOCUS ON EFFECTS OF EPA AND DHA ON MORTALITY ACROSS DIVERSE SETTINGS AND COMPARISON OF TRANSLATIONAL PATTERNS IN TWO NUTRIENT-DISEASE ASSOCIATIONS AND IDENTIFYING SIGNALS FOR UPDATING SYSTEMIC REVIEWS. AN OVERALL OUTCOME OF ALL THIS IS THAT THIS EFFORT BY ODS IN PARTNERSHIP WITH ARHQ DEVELOPED A DEEP POOL OF EFFORTS FOR SYSTEMIC REVIEWS IN NUTRITION. I THINK THIS IS AN IMPORTANT OV OV OVERALL OUTCOME AND WENT TO THOSE WHO UNDERSTAND THE RIGOR AND TRANSPARENCY AND OBJECTIVE APPROACH THAT WELL DONE HIGH QUALITY SYSTEMIC REVIEWS HAD AND HELPED A FIELD MOVE FORWARD IN HOW SYSTEMIC REVIEWS WERE CONDUCTED, REPORTED AND APPLIES TO DECISION MAKE IN THE FIELD AND I THINK THIS WAS REALLY CRITICAL TO THE DEVELOPMENT OF THE FIELD. BEFORE I MOVE ON THOUGH I WANT TO SPEND A FEW MINUTES ON SOME OF THE CHALLENGES AND ISSUES THAT WERE IDENTIFIED BY THESE TECHNICAL REPORTS IN TERMS OF CONDUCTING NUTRITION SYSTEMIC REVIEWS AND THESE ARE GOING TO LOOK VERY FAMILIAR TO YOU BECAUSE YOU HEARD ABOUT THESE YESTERDAY FROM A NUMBER OF THE SPEAKERS. THE CHALLENGE OF BASELINE EXPOSURE AND A NUMBER OF THE SPEAKERS YESTERDAY SPOKE ABOUT THIS NOT JUST IN TERMS OF NUTRIENTS BUT IN TERMS OF BOTANICALS AND THIS IS ONE OF THE BIG DIFFERENCES BETWEEN DRUG EXPOSURE WHERE YOU HAVE WHAT SOME IN NUTRITION FIELD CALLED A TRUE PLACEBO AND THE REALITY OF NUTRITION WHICH IS PEOPLE ARE EXPOSED TO SOME BASELINE LEVEL. ONE OF THE RECOMMENDATIONS IS THE INFORMATION ON BACKGROUND INTAKES AND THE METHODOLOGIES USED TO ASSESS THEM SHOULD BE CAPTURED IN SYSTEMIC REVIEWS. AND A MUST TELL YOU THAT THIS CHALLENGE STILL REMAINS BUT THE APPROACH RECOMMENDED HERE IS NOT ALWAYS INCLUDE IN SYSTEMIC REVIEWS. IN PART I THINK IN FAIRNESS TO THE FIELD. AND THERE WAS THE ISSUE OF NUTRIENT STATUS AND THE STATUS CAN EFFECT RESPONSES TO NUTRIENT SUPPLEMENTATION. YOU HEARD SOME OF THESE FROM DR. MANSON AND THAT MEANS STATUS OF THE INDIVIDUALS NEEDS TO BE ASSESSED AND CAPTURED BUT OFTEN IS NOT. THE CHEMICAL FORM OF THE NUTRIENT OR DIETARY SUPPLEMENT WAS ALSO DISCUSSED AND THIS IS AN IMPORTANT ISSUE BECAUSE FORMS VARY. ONE OF THE RECOMMENDATIONS WAS TO ASSURE BIO EQUIVALENCE OR HOW CONVERSION FACTORS ARE USED IN MAKING APPROPRIATE INTERPRETATION AND META-ANALYSIS. ALSO NOTED AS A CHALLENGE WERE FACTORS THAT INFLUENCE BIO AVAILABILITY AND THE NEED TO CAPTURE SUCH INFORMATION OF THE INFLUENCES IN THE SYSTEMIC REVIEW. ANOTHER CHALLENGE WAS MULTIPLE AND INTERRELATED FUNCTIONS OF NUTRIENT OR DIETARY SUBSTANCES AND THIS IS A CHALLENGE THAT CONTINUES AND AN ISSUE TO A SYSTEMS APPROACH TO BUT DOES AFFECT THE INTERPRETATION AND THIS PROBABLY NEEDS SOME METHODS DEVELOPMENT. ANOTHER CHALLENGE IS THE NATURE OF THE NUTRIENT OR DIETARY SUPPLEMENT WHETHER IT'S A SUPPLEMENT OR FOOD BASED OR DIET-BASED APPROACH AND NEEDS TO BE CAPTURED IN THE SYSTEMATIC REVIEW AND DOSE RESPONSE RELATIONSHIPS. THE RECOMMENDATION WAS TO HAVE MEASUREMENT ON THE ASSAY AND PROCEDURES AND I WOULD SAY THIS IS AN AREA WHERE I HAVE SEEN IN BOTH THE DRI REVIEW COMMITTEES A REAL NEED FOR SOME INNOVATIVE METHODS DEVELOPMENT BECAUSE OFTEN WE HAVE CAUSAL EVIDENCE FROM RANDOMIZED CLINICAL TRIALS WITH ONLY A SINGLE OR IF WE'RE LUCKY TWO DOSES AND OBSERVATIONAL EVIDENCE THAT GIVES US LESS CERTAIN BUT MORE DIVERSE DOSE RESPONSE AND I THINK THAT THERE'S ROOM THEN FOR METHODS DEVELOPMENT HERE. SO THIS APPROACH AND THIS CRITICAL ANALYSIS OF THE CHALLENGES I THINK IS REALLY AN IMPORTANT OUTCOME THAT STILL HELPS GUIDE WHAT WE DO IN THINKING ABOUT HOW WE IMPROVE OUR EVIDENCE-BASED REVIEW PROCESS IN THE FUTURE. NOW, ONE OF THE INTERESTING THINGS THAT WAS DONE IS A PART OF THE TECHNICAL REPORTS WAS ON A CRITICAL ANALYSIS OF THE REPORTING QUALITY OF NUTRITION OF SYSTEMATIC REVIEWS. THIS WAS REPORTED IN 2009 AND YOU CAN SEE THAT MANY, MANY NUTRITION REVIEWS DID NOT REPORT RECOMMENDED ITEMS. ONLY 40%. AND IMPROVING THE REPORTING OF SYSTEMATIC REVIEWS MOVING FORWARD FROM 2009 IS ESSENTIAL. IT WOULD BE INTERESTING I THINK TO SEE WHAT IS SIMILAR ANALYSIS TODAY WOULD REVEAL IN TERMS OF HOW WELL REPORT AND THE QUALITY OF SYSTEMATIC REVIEWS ESPECIALLY NOW THAT WE HAVE 200 TO 300 A YEAR. THE OTHER ISSUE IS THAT THE REPORTING QUALITY OF SYSTEMATIC REVIEWS IMPROVED WITH STANDARDS INCLUDING THE IOM STANDARDS FOR SYSTEMATIC REVIEWS PUBLISHED IN 2008 BUT THIS DID NOT HAPPEN INFUSION -- NUTRITION. IN TERMS OF UPDATING SYSTEMATIC REVIEWS THERE WAS A PILOT STUDY USING TWO APPROACHES. THERE WAS SUBSTANTIAL AGREEMENT ON THE NEED TO UPDATE A SYSTEMATIC REVIEW SO THE CONCLUSION WAS YOU COULD USE EITHER APPROACH. THE AUTHORS SUGGESTED FACTORS IN SELECTING THE METHOD. ONE WAS LOW LEVEL OF EXPERT ENGAGEMENT IN THE RESEARCH TOPIC MIGHT MEAN YOU WOULD SELECT THE QUALITATIVE METHOD BECAUSE OF THE EXPERTISE NEEDED NOT BEING AVAILABLE. AND THE OTHER WAS STUDY GUIDE DESIGNS MIGHT LEAD YOU TO SELECT EXPERT GUIDANCE. AND CONSIDERING ABSOLUTE LEVELS OF PRIOR EVIDENCE RATHER THAN RELATIVE LEVELS YOU MAY SELECT EXPERT GUIDANCE. IF THERE WAS A HIGH DESIRE FOR A TRANSPARENT SIGNALLING METHOD THAT MAXIMIZED AND I THINK THIS IS IMPORTANT BECAUSE AS YOU SAW A NUMBER OF THE REVIEWS THAT ODS SPONSORED ARE NOW GETTING RATHER MATURE IS THE WORD I WOULD USE AND PERHAPS GOING TO BE NEED TO UPDATE THEM IN THE FUTURE. THERE'S ALSO THEN WERE TWO NUTRITION RESEARCH TECHNICAL REPORTS THAT WERE SPONSORED BY ODS THAT RELATED TO APPLYING EVIDENCE SYNTHESIS IN DECISION MAKING AND THEY RELATED TO SPECIFYING THE DIETARY REFERENCE INTAKES. THE FIRST SYSTEMIC REVIEW EVER USED IN A DRI WAS IN CALCIUM IN VITAMIN D AND TO ENABLE CLARITY AND TRANSPARENCY AND RELEVANCE OF SYSTEM REVIEW QUESTIONS WAS NOTE ED BY THIS TECHNICAL REPORT AND PROPOSED A GENERIC ANALYTIC FRAMEWORK FOR EXPOSURE AND HEALTH OUTCOME STILL USED IN THE SYSTEMATIC REVIEWS AS THEY'RE DONE TO INFORM THE DIETARY REFERENCE INTAKES. AND THE MAJOR ONE OF THESE IS THE SELECTION OF CRITICAL OUTCOMES FOR NUTRIENT REFERENCE VALUES. THEY NOTES D WE DON'T HAVE CONSENSUS AND I THINK IT REMAINS AN IMPORTANT ISSUE. AND THE SYSTEMATIC REVIEW PANEL IS CRITICAL BUT OUTCOMES MAY DIFFERENT WITH DIFFERENT PANELS AND ESTABLISHING INSTRUCTIONS HOW TO WEIGH OUTCOMES MAY ELIMINATE VARIABILITY AND THE USE OF AN EVIDENCE MAP MIGHT HELP FACILITATE DECISIONS. ANOTHER ISSUE THAT WAS NOTED WAS USE OF EXISTING SYSTEMATIC REVIEWS AND THIS REMAINS A TECHNICAL CHALLENGE AS WELL. I WANT TO MOVE BEYOND THE EVIDENCE-BASED REVIEW IN THE LAST TWO MINUTES I HAVE AND TALK ABOUT THE OPTIONS FOR CONSIDERING CHRONIC DISEASE END POINTS IN DRI. PART OF WHAT I WANT TO TALK ABOUT IS HOW THE FOUNDATION OF THE EVIDENCE-BASED REVIEW PROGRAM THE RIGOR, THE SYNTHESIS AND TRANSPARENCY AND STRUCTURE AND THE ABILITY TO APPLY THIS TO DECISION MAKING RESULTED IN THE BASE FROM WHICH CHRONIC DISEASE EVIDENCE HAS ITS OWN ISSUES AND HOW TO THINK OF THIS FOR DEVELOPING REFERENCE VALUES IS WORTH THINKING ABOUT AND THE U.S. AND CANADA WORKING GROUP AND ODS WORKSHOP ON OPTIONS FOR CONSIDERATION OF CHRONIC DISEASE END POINTS WAS A NEXT STEP IN THIS PROCESS IN 2015 AND ODS PARTNERED WITH CANADA AND OTHER U.S. FEDERAL SPONSORS IN THIS EFFORT. THIS RESULTED IN THIS TIME AND IT TAKES US BACK TO THE ISSUE OF HOW WE SYNTHESIZE AND JUDGE THE QUALITY OF A BODY OF EVIDENCE FOR DECISION MAKING. IT'S ABOUT THE TOTALITY OF THE EVIDENCE AND THE QUALITY OF THE EVIDENCE. YOU'LL SEE ON THE RIGHT THE WELL KNOWN HIERARCHY QUALITY OF EVIDENCE WITH SYSTEMATIC REVIEWS AND META-ANALYSIS OF RCTs AND VARIOUS KINDS OF OBSERVATIONAL STUDIES. AND THE GUIDELINES RECOMMENDS MODERATE STRENGTH OF THE TOTALITY OF EVIDENCE FOR CAUSAL ASSOCIATION FOR A NUTRIENT OR NATURALLY OCCURRING FOOD SUBSTANCE WITH A SINGLE OUTCOME OF CHRONIC DISEASE OR A SURROGATE OUTCOME. YOU'LL NOTICE THE BODY OF EVIDENCE THAT'S INCLUDED HERE IS BY THE VERY NATURE DIFFERENT THAN THAT FROM ADEQUACY AND MORE EVIDENCE MAY COME FROM OBSERVATIONAL STUDIES THAN RCTs AND MAY BE A LOWER CERTAINTY OF CAUSAL RELATION AND MORE OF A USE OF QUALIFIED SURROGATE OUTCOMES AND INHERENTLY OPEN TO A HIGHER RISK OF BIAS WHETHER DUE TO PUBLICATION. I THINK THE CONNECTION I SEE BEYOND THE EVIDENCE-BASED REVIEW HOW WE CONSIDER CHRONIC DISEASES GETS US SQUARELY BACK TO THE HEART OF THE EVIDENCE BASED REVIEW PROGRAM HOW WE COLLECT AND SYNTHESIZE AND INTERPRET THE TOTALITY OF A BODY OF EVIDENCE. THE GUIDING PRINCIPLES REQUIRE MODERATE STRENGTH OF EVIDENCE FOR INTAKE DOSE RESPONSE OF NUTRIENTS OR A NATURALLY OCCURRING FOOD SUBSTANCE. THIS HAS RESULTED IN AN EXPANSION OF THE DRI PARADIGM. WHAT IS NOW THE HEALTH OUTCOME IS ADEQUACY OUTCOME. CHRONIC DISEASE CANNOT BE INCLUDE AND NOW THE OUTCOME FOR A TOLERABLE UPPER LEVEL IS TOXICITY AGAIN CHRONIC DISEASE CANNOT BE CONSIDERED. AND A CHRONIC DISEASE RISK REDUCTION AND THE RELATION OF INTAKE CAN VARY AS SHOWN BY THE THREE AND TIPPEDED TO INDICATE THE INTAKE CAN VARY ON THE NUTRIENT. >> WE'RE RUNNING OUT OF TIME FOR YOUR SECTION CAN YOU DO A WRAP-UP? >> WE THINK THIS SYNERGIZED REVIEW AND IT'S TIME TO THINK ABOUT WHAT'S NEXT AND HOW TO THINK WITH THE OMICS AND HAVE UPDATES AND OF REVIEWS. HOW WE IDENTIFIED NEEDS FOR NEW INNOVATIVE APPROACHES AND HOW TO REVIEW THE DEPTH OF REVIEW IN EXPERTISE AND NUTRITION. THANK YOU VERY MUCH. >> THANK YOU FOR THAT WONDERFUL SUMMARY AND OVERVIEW. I WANTED TO REMIND YOU IF YOU HAVE QUESTIONS FOR ANY OF THE PANELISTS PLEASE ENTER THEM INTO THE Q&A SECTION OF WEBEX WE'LL HAVE A FEW MINUTES AT THEN OF THIS SECTION OF THE WORKSHOP TO TAKE YOUR QUESTIONS AND ANSWERS AND PROVIDE SOME ANSWERS IN ADDITION YOU CAN ALSO ALWAYS WRITE TO ODS WHEN YOU FIND THE CONTACT US BUTTON ON THE WEBSITE AND ASK US THOSE QUESTIONS. ANY QUESTIONS THAT DON'T GET ANSWERED TODAY. NOW WE'RE GOING TO MOVE ON TO OUR NEXT SPEAKER AND SECTION. THE NEXT IS DR. CHRISTINE TAYLOR. THE CHAIR OF THE AMERICAN NUTRITION SOCIETIES ON ADVOCACY AND SCIENCE POLICY. SHE HAS A DISTINGUISHED CAREER AND I HOPE I ENCOURAGE YOU TO GO TO THE LIST OF THE BIO SCETCHES -- SKETCHES AND READ HERE'S AND SHE'LL TALK ABOUT THE VITAMIN D INITIATIVE AND FOCUS ON POPULATION STUDIES, LITERATURE REVIEWS AND RECOMMENDED DIETARY ALLOWANCES. >> IN THE 1930s THE U.S. BEGAN FORTIFYING MILK AND IT MAY HAVE SEEM RESOLVED BUT BEGINNING 20 YEARS AGO WE BEGAN TO SEE HIGHER THAN EXPECTED NUMBERS OF PERSON BEING LABELED AT RISK FOR VITAMIN D ADEQUACY. THE MEASURES USED APPEARED TO HAVE CHANGED OVER TIME. NOT AGREED UPON OR EVEN NECESSARILY LINKED TO ADVERSE OUTCOMES. IT WAS NOTED AN INCREASING NUMBER OF PERSONS WERE LACTOSE IN TOLERANT AND CONSUMPTION OF DAIRY PRODUCTS WERE DECLINING AND RESEARCHERS BEGAN TO STUDY THE EXPAND WILL ROLE FOR VITAMIN D AND THE ENTIRE SITUATION IS COMPLICATED BY THE FACT THAT VITAMIN D FUNCTIONS AS A HORMONE AND THERE WAS A ROLE FOR SUNLIGHT AND DIETARY INTAKE. WHAT WAS CLEAR IS THERE WERE MANY OUTSTANDING ISSUES TO BE RESOLVED. ROLES OF VITAMIN D WERE NOT ENTIRE CLEAR AND IMPORTANTLY THE APPROACHES TO DETERMINING STATUS WERE PROBLEMATIC AND RANGE FROM VARIED AND INCONSISTENT LABORATORY METHODS TO WHICH BIOMARKERS REFLECTED STATUS TO SPECIFYING HOW MUCH IS NEEDED BY THE BODY. ADD TO THIS THE GROWING INTEREST IN RECOMMENDING VITAMIN D SUPPLEMENTS TO REDUCE THE ASSUMED DEFICIENCY COUPLED WITH THE GROWING PRACTICE OF VOLUNTARILY FORTIFYING MORE FOODS WITH VITAMIN D AND THE RESULT IS A PUBLIC HEALTH CONUNDRUM. ODS STEPPED UP AND THAT'S THE STORY OF THE VITAMIN D INITIATIVE. OFFICE HAD THE GRAVITAS AND NEEDED TOOLBOX TO COME UP WITH WISE LEADERSHIP. FIRST, THE ODS HAS THE SKILL SET TO SERVE IN A STEERING ROLE IF NEEDED. THEN THERE'S THE ODS EMPHASIS ON COLLABORATION. COLLABORATE ON DEVELOPMENT, COLLABORATE ON SPONSORSHIP AND COLLABORATE ON FUNDING. ODS EVIDENCE REST ON RELEVANCE AND TIMELINESS. KNOWLEDGE GAPS CAN BE ADDRESSED THROUGH A RANGE OF ACTIVITIES INCLUDING CONFERENCES AND WORK SHOPS, EVIDENCE-BASED SYSTEM REVIEWS AND ASSESSMENTS AND SPECIAL STUDIES. THERE WERE ALSO COLLABORATIVE EFFORTS TO STANDARDIZE MEASUREMENT. THE ACTIVITY IN THE BOX WILL BE THE SUBJECT OF THE NEXT PRESENTATION AND WILL NOT BE COVERED HERE. SO WE HAVE THE WHY FOR THE INITIATIVE BUT WHAT ABOUT THE HOW? UNDERSTANDABLY IT'S BEEN A STEP WISE PROCESS. 2003 ODS ORGANIZED A CONFERENCE COLLABORATIVELY PLANNED WITH GROUPS. FIRST THING'S FIRST. THE CONFERENCE WAS INTENDED TO LAY OUT THE PROBLEM AND IDENTIFYING KNOWLEDGE GAPS AND DATA NEEDS. THERE WAS A BROAD RANGE OF TARGETED INTEREST INCLUDING BIOMARKERS AND DOSE RESPONSE RELATIONSHIPS, BETTER STATUS DEFINITIONS, RE-EVALUATION OF INTAKE REQUIREMENTS AND OTHERS. THE DISCUSSION AND ESSENCE WERE TO DEFINE AND FOCUS THE PROBLEM SO RELEVANT WORK WOULD FOLLOW. BASED ON SEVERAL 2003 INVESTIGATIONS ANOTHER COLLABORATIVE EFFORT, SORRY, IN 2007, CONTRACTED FOR AHRQ CONDUCTED A REVIEW AND HIGHLIGHTED THE NATURE AND QUALITY OF AVAILABLE EVIDENCE. ODS UPDATE THE KNOWLEDGE GAPS IDENTIFIED BY THE FIRST CONFERENCE. ODS ALSO SUPPORTED A REVIEW FOCUSSED ON DESCRIBING THE DATA ON VITAMIN D STATUS AS WELL AS AND A DISCUSSION INTO RESEARCH NEEDS. KEEP IN MIND AT THE SAME TIME, ODS AND OTHERS WERE WORKING ON THE MEASUREMENTS STANDARDIZATION A REVIEW OF THE RESEARCH REPORTS AND DETERMINATION WAS TIMELY. IN 2009 ODS HAD AN EFFORT TO AGAIN FUND AN AHRQ REVIEW THIS TIME FOCUSSED ON OUTCOMES OTHER THAN BONE HEALTH AS THEY RELATE TO VITAMIN D AND CALCIUM. ON A PARALLEL TRACK AND LED BY ODS, A GROUP OF U.S. FEDERAL AGENCIES AND CANADIAN GOVERNMENT PUBLISHED AN ASSESSMENT OF THE DIETARY REFERENCE INTAKES FOR VITAMIN D WHICH HAD LAST BEEN REVIEWED BY THE INSTITUTE OF MEDICINE AND ACADEMIES OF 1997. SHORTLY THEREAFTER THE INSTITUTE OF MEDICINE CONVENED AN EXPERT CONSENSUS TO REVIEW THE DRIs FOR VITAMIN D AND CALCIUM AND THE REPORT WAS COMPLETED IN LATE 2010. A DEMONSTRATION OF THE INITIATIVE WAS NOT ONLY BUILT STEP BY STEP BUT SERVED TO ESTABLISH A BASE OF INFORMATION TO BE USED BY OTHERS. THIS IOM EXPERT COMMITTEE MADE EXTENSIVE USE OF THE TWO AHRQ REVIEWS CARRIED OUT IN 2007 AND 2009. THE PUBLICATION OF THE NEW DRIs IN 2010 WAS A WATERSHED MOMENT AND COLLABORATION BETWEEN ODS AND USDA CONCLUDE THE MEASURE OF THE FOODS CONTAINED IN THE SURVEYS, 25OHS BEING A METABOLITE OF VITAMIN D IN ANIMAL FOODS, THIS FAILURE WITH PERSONS WITH LOW INTAKE OF VITAMIN D SEEMED TO HAVE REASONABLE VITAMIN D STATUS. IN 2015 A CONFERENCE WAS ORGANIZED TO CONSIDER THE SERUM LEVELS OF VITAMIN D AND HEALTH OUTCOMES IN CERTAIN POPULATIONS MOST NOTABLY BLACK AMERICANS. THIS WAS AN ISSUE RAISED BY THE DRI WORKING GROUP. ALSO, AS ANOTHER FOLLOW-ON TO THE REVIEW, COLLABORATIVE CONVERSATION WAS ORGANIZED TO EXPLORE IMPROVED DECISION MAKERS AND SET IN THE CONTEXT OF NEEDED RESEARCH. ODS ALSO CONTINUED ITS FINANCIAL SUPPORT AND IMPORTANTLY VITAMIN D STANDARDIZATION PROGRAM BECAME AN INCREASING FOCUS OF THE INITIATIVE. SO, BY SEEK COLLABORATION, EATING AS NECESSARY AND DOING THE BASIC WORK OF IDENTIFYING THE NEEDS AND SEEKING SOLUTIONS, ODS SERVED AN IMPORTANT ROLE WHEN IT COMES TO OUR CURRENT UNDERSTANDING OF VITAMIN D. WE NOW HAVE MORE AND BETTER INFORMATION ABOUT VITAMIN D THANKS TO THE INITIATIVE. AND WHEN TAKEN TOGETHER THE INITIATIVE OUTCOMES SERVED TO INFORM AND ASSIST OTHERS IN THE FIELD OF ACADEMIA AND THE VITAMIN D STORY DOES NOT END HERE. THERE'S MANY EMERGING AND NEW ISSUES AND MANY DIFFERENT VIEWS ON WHAT IS MOST CRITICAL. BY WAY OF CLOSING, I WILL MENTION TOO THAT WE SHOULD WORK TOWARDS AGREEMENT TO PERSONS AT RISK OF VITAMIN D INSUFFICIENCY AND LOOK AT THE CUT POINTS VERSUS THE MEDICINE APPROACH TO CLASSIFYING STATUS BY WAY OF PROBABILITY METHOD. TWO, WE SHOULD BE MINDFUL VITAMIN D SUPPLEMENTATION AND FOOD FORTIFYING IS A BALANCE AND VITAMIN D STATUS CAN BE DETERMINED BY SERUM LEVEL ABOVE OR BELOW YOU'RE ADEQUATE OR NOT. OTHERS SUGGEST AS IN THE ARTICLE SHOWN IN THE TOP HALF AND THERE'S A PROBLEM FOR RISK AND IT'S BEEN SUGGESTED AS SHOWN IN THE BOTTOM HALF THIS MISUSE OF THE DRIs CAUSE AS A FALSE CONCLUSION WE HAVE THE PANDEMIC OF VITAMIN D DEFICIENCY. THIS NEEDS TO BE RESOLVED BUT EVEN IF YOU CHOOSE TO USE CUT POINTS AND THIS SHOWS VALUES OF SPECIFICITY. THERE'S A RANGE AND FOOD FORTIFICATION CAN BE A BLUNT INSTRUMENT AS COMES TO WIDESPREAD USE OF VITAMIN D AND SUPPLEMENTS. WE NEED TO BE AWARE AS THIS PARTICULAR ALLOCATION POINTS OUT THAT WHILE WE CONTINUE TO WORK TOWARDS IMPROVED STATUS FOR GROUPS AT RISK, OTHER GROUPS WITHIN THE POPULATION MAY BE EXPOSED TO AN UNNECESSARILY HIGH VITAMIN D INTAKE ON THE BASIS AS SUGGESTS BY THE AUTHORIZE ON THE BASIS OF UNSUBSTANTIATED CLAIMS AND IT'S A BALANCING ACT THAT REQUIRES THIS. I'LL SAY THANK YOU AND CONGRATULATIONS ON AN IMPRESSIVE BODY OF WORK ON VITAMIN D. >> THANK YOU. WE APPRECIATE IT. WE'LL CONTINUE WITH THE VITAMIN D INITIATIVE DISCUSSION AND THE NEXT SPEAKER IS DR. CHRISTOPHER SEMPOS. DR. SEMPOS WILL GIVE A PRESENTATION ON THE VITAMIN D STANDARDIZATION PROGRAM FOR WHICH HE'S BEEN THE COORDINATOR SINCE 2010. PLEASE GO AHEAD. >> THANK YOU FOR THE INTRODUCTION AND THE OPPORTUNITY TO SPEAK UNDER THE LEADERSHIP OF THOSE WITH STANDARDIZATION PROGRAM. MY PRESENTATION FOLLOWS DIRECTLY OF THE EXCELLENT PRESENTATIONS THIS MORNING BY DOCTORS BRANNON AND TAYLOR. I HAVE -- >> SORRY FOR THE INTERRUPTION. WE NEED YOU TO START THE SLIDE SHARING. IT'S NOT COMING THROUGH. >> WHAT DO I NEED TO DO? >> CLICK THE SHARE BUTTON AT THE BOTTOM OF THE WEBEX WINDOW. >> THANK YOU VERY KINDLY. AGAIN, THANK YOU FOR YOUR KIND INTRODUCTION. I APOLOGIZE FOR MY INABILITY TO GET THIS RIGHT FROM THE START. I WOULD ALSO LIKE TO THANK YOU FOR THE OPPORTUNITY TO SPEAK ABOUT ANOTHER ODS SUCCESS STORY UNDER THE LEADERSHIP OF DOCTORS PAUL COTES AND JOSEPH BES. THE VITAMIN D STANDARDIZATION PROGRAM OR THE VDSP. MY PRESENTATION FOLLOWS DIRECTLY ON THE EXCELLENT PRESENTATIONS THIS MORNING BY DOCTORS BRANNON AND TAYLOR. I HAVE NOTHING TO DISCLOSE AND THE POPULATIONS PROGRAM IN 2010 INDICATED THERE WAS A NEED FOR NIH TO TAKE THE LEAD IN FILLING GAPS IN VITAMIN D KNOWLEDGE. ESPECIALLY IN REFERENCE MATERIALS AND ANALYTICAL METHODS DEVELOPMENT. ODS PROPOSED THE STANDARDIZATION PROGRAM AS A COMPONENT OF THE MULTI-PRONG VITAMIN D INITIATIVE BEGUN BY DOCTORS JOSEPH BETTS WELL THEN WHAT DO WE MEAN BY VITAMIN D STANDARDIZATION? WE PRIMARILY MEAN THE EFFORT TO STANDARDIZE THE MEASUREMENT OF TOTAL 25 HYDROXY D CONCENTRATION. THE PRINCIPLE MEASURE OF VITAMIN D STATUS. IN THE NEXT SLIDE AS DOCTOR TAYLOR MENTIONED, NOTICE THE GREAT RANGE OF CONCENTRATIONS USED TO DEFINE DEFICIENCY IN RED AND INSUFFICIENCY IN ORANGE AND SUFFICIENCY IN GREEN. THE SETS OF GUIDELINE. THE QUESTION IS WHICH IS THE BEST? IN MY MIND, THAT IS THE FUNDAMENTAL QUESTION IN VITAMIN D RESEARCH. GIVEN THE GREAT MANY VITAMIN D STUDIES, CLINICAL TRIALS AND META-ANALYSIS WHY HAVEN'T WE BEEN ABLE TO ANSWER THE QUESTION. IT'S DUE IN LARGE PART TO ASSAY VARIATION AS IT CONFOUNDS THE DIAGNOSIS OF HYPOVITAMIN D. THE FULCRUM UPON WHICH THE DEFINITION OF ALL OTHER VITAMIN D STATES REST. BUT WHY IS ASSAY VARIATION SO IMPORTANT? IT'S IMPORTANT BECAUSE IT MAKES IT IMPOSSIBLE TO COMPARE THE LEVELS FROM DIFFERENT STUDIES. AND THE NEXT SLIDE WE SEE AN EARLY EXAMPLE OF DATA ON ASSAY VARIATION FROM 2008, THESE ARE THE FIRST DATA TO DOCUMENT THE EXTEND OF BIAS FROM THE HYDROXY CONCENTRATION BY ASSAY TYPE. AND THE TWO NOTED ASSAYS ARE THE GCMS AND THE OTHER CONTINUED. MOST IS AS WERE POSITIVELY BIASSED WITH THE LCMS ASSAYS. THOSE WERE THOUGHT TO BE THE MOST ACCURATE AND PRECISE METHODS WITH AN AVERAGE 12% BIAS. WHAT THEN IS ASSAY STANDARDIZATION. WITH ASSAY STANDARDIZATION WE SEE ALL LABORATORIES REGARDLESS OF TIME, LOCATION OR ASSAY TYPE GETTING THE SAME RESULT. AND IT MAKES META-ANALYSIS OF POOL STUDIES POSSIBLE. THAT ALLOWS FOR THE DEVELOPMENT OF CLINICAL AND PUBLIC HEALTH GUIDELINES BASED ON THE TRUE OHDTRATIOHD CONCENTRATION AND LET'S LOOK AT THE EFFECTS STANDARDIZATION CAN HAVE. AND THE TREND DISAPPEARED COMPLETELY. THE OTHER EXAMPLE SHOWS WHAT THE STANDARDIZATION CAN HAVE EFFECT AND THERE'S A U-SHAPE RELATIONSHIP BETWEEN SERUM OHD AND ALL CAUSES MORTALITY. THAT IS PEOPLE AT THE HIGHEST 25OHD CONCENTRATION LEVEL WERE AT RISK OF DYING. BUT WITH ASSAY STANDARDIZATION, AGAIN, THE U-SHAPED ASSOCIATION DISAPPEARED ENTIRELY. ACCORDINGLY, THE GOAL OF THE STANDARDIZATION PROGRAM IS TO PROMOTE THE STANDARDIZED LABORATORY MEASUREMENT OF 25OHD TO CLINICAL AND PUBLIC HEALTH PRACTICE WORLDWIDE. AND AS THE VAST MAJORITY OF 25OHD MEASUREMENTS ARE MADE WITH COMMERCIAL ASSAYS, THE OBJECTIVES FOR FOCUS ON PROMOTING COMPETITION AMONG COMMERCIAL ASSAY MANUFACTURES BY CONDUCTING AN ANALYTICAL METHODS RESEARCH PROGRAM ALL TO PROMOTE STANDARDIZED MEASUREMENTS IN NATIONAL SURVEYS IN ASSAYS WORLDWIDE. STANDARDIZATION HAS SEVERAL PHASES BUT BEGINS WITH THE DEVELOPMENT OF A REFERENCE MEASUREMENT SYSTEM. ON THE RIGHT ARE THE TOOLS NECESSARY TO ACCOMPLISH EACH PHASE. THOSE ARE COMPONENTS OF THE REFERENCE MEASUREMENT SYSTEM. THEREFORE IN ORDER TO MOVE FROM ONE PHASE TO THE NEXT THE MOST IMPORTANT TASK WAS A DEVELOPMENT IN THE REFERENCE MEASUREMENT SYSTEM. IT STARTS WITH THE DEVELOPMENT OF MISSED REFERENCE METHODS AND MISSED STANDARD REFERENCE MATERIALS ALL DEVELOPED AND WITH ODS. AND JUST RELEASED ARE TWO MISSED SRNs, 2969 AND 2970 CONTROLS FOR LOW AND HIGH 25 OHD CONCENTRATIONS. THEN VERIFY USER PERFORMANCE USING TRUE 25 HYDROXY D CONCENTRATION IN TEST MATERIALS FROM SEVERAL PROGRAMS YOU CAN EVALUATE AND USER PERFORMANCE. OTHER ACHIEVEMENTS WERE THE DEVELOPMENT OF PERFORMANCE STANDARDS FOR DEFINING STANDARDIZATION AND THE PUBLICATION OF PROTOCOLS AND STATISTICAL TOOLS FOR BOTH PROSPECTIVE AND RETROSPECTIVE STANDARDIZATION WHERE PROSPECTIVE STANDARDIZATION IS STANDARDIZATION OF CURRENT AND FUTURE STUDIES AND RETROSPECTIVE STANDARDIZATION IS A STANDARDIZATION OF OLD STUDIES. THEN WITH THOSE TOOLS THE VDSP HAVE EVALUATED A SERUM SAMPLES FROM MISSED SRMs AND PERFORMANCE METH SURVEYS PERFORMED LIKE PATIENT SAMPLES. WE'VE ALSO EVALUATED TRENDS AND ACCURACY BIAS AND PRECISION IN TWO STUDIES FOR A NUMBER OF THE MOST COMMONLY USED ASSAYS. VDSP HAS COLLABORATED ON THE STANDARDIZATION OF ALL NHANES SERUM MEASUREMENTS FROM THE START OF THE COLLECTION OF THOSE MEASUREMENTS IN 1988 AS PART OF THE N HANES AND ODS PARTICIPATED IN THE STANDARDIZATION OF A DRIED BLOOD SPOT ASSAYS. IN ADDITION TO THIS EFFORT, HAS LED TO STANDARDIZATION AROUND THE WORLD AND THOSE E.U. FUNDED STUDIES LED BY PROFESSORS FROM CORK UNIVERSITY AND IOWA. >> TWO MINUTES. >> PARDON ME, MA'AM? >> TWO MINUTES, PLEASE. >> YES, MA'AM. WHILE INCLUDING THE VITAL STUDY THE ONLY CLINICAL TRIAL WITH STANDARDIZED 25 OHD VALUES AS A RESULT OF ODS FUNDING. AS SHOWN ON THE SLIDE IF WE CONTINUE TO PUBLISH THOUSANDS OF VITAMIN D PAPERS A YEAR -- YET WE CONTINUE TO PUBLISH THOUSANDS OF PAPERS A YEAR AND WITH ALL META-ANALYSISES PUBLISHED, ONLY ONE META-ANALYSES IS BASED ON THE MEASUREMENTS. ASK YOURSELVES, WHICH SET OF GUIDELINES IS BEST? UNFORTUNATELY, WITH ALL THE ACHIEVEMENTS OF THE VITAMIN D STANDARDIZATION PROGRAM WE'RE STILL A LONG WAY FROM THAT GOAL. PATH TO THE FUTURE IS STANDARDIZE ALL NEW VITAMIN D RESEARCH AND MOST IMPORTANTLY KEY RESEARCH CONDUCTED IN THE PAST. THERE ARE A GREAT MANY PEOPLE AROUND THE WORLD WHO CONTRIBUTED TO THE SUCCESSION THE VDSP AND THAT'S TRUE FOR THE COLLABORATIVE EFFORT OF ODS. I'D LIKE TO PAY SPECIAL TRIBUTE TO DR. PAUL COTES AS HIS VISION MADE IT ALL POSSIBLE. THANK YOU VERY MUCH AND HAPPY 20th. -- 25th. >> THANK YOU VERY MUCH, DR. SEMPOS. THAT WAS A WONDERFUL SUMMARY OF THE VDSP. NEXT WE'LL DISCUSS THE IODINE INITIATIVE. I'D LIKE TO TURN IT OVER TO MY COLLEAGUE DR. ABBY ERSHOW A SENIOR NUTRITION SCIENTIST. SHE'LL INTRODUCE YOU TO THE IODINE INITIATIVE. GO AHEAD. >> HELLO. I WAS A HEART, LUNG AND BLOOD INSTITUTE AS A PROGRAM OFFICER AND I CAME TO ODS AND PAUL COATS SAID I WOULD LIKE YOU TO TAKE OVER THE IODINE PORTFOLIO. AND A THOUGHT, IODINE, YOU HAVE TO BE KID. >> PRESS THE SHARE BUTTON. >> GOT IT. >> I APOLOGIZE, EVERYBODY. >> WELL, THOSE WHO CAN LOOK BACK FAR ENOUGH, WELL, REMEMBER IODIZED SALT AND BY 2013 THE SALES WERE EVALUATED ON THE RETAIL LEVEL AND ONLY REPRESENTED ABOUT HALF OF THE RETAIL SALT. WHY IS THIS? WELL, IF YOU LOOK AT THE PICTURES TO THE RIGHT, THAT'S WHAT A SALT SHELF IN A GROCERY LOOKS LIKE NOW. PINK HIMALAYAN SEA SALT AND BOUTIQUE SALT. THEY'RE NOT IODIZED. THERE'S BEEN OTHER CHANGED DR. PEARCE WILL TALK ABOUT WHEN HES -- HE FOLLOWS ME. IODINE HAS BEEN ON THE RADAR AT ODS OVER 10 YEARS AND FIRST LOOKED AT BY A GREAT EXPERT IN CHILD AND MATERNAL NUTRITION. AND THERE WAS A FACET SYMPOSIUM LOOKING AT WHETHER PRENATAL SUPPLEMENTS WERE MATCHING WHAT WERE KNOWN TO BE THE NUTRIENT NEEDS OF PREGNANT WOMEN. TURNED OUT THE INDICATION OF SOMETHING OF A GAP. AFTER THAT A NUMBER OF OTHER SYMPOSIA AND NICHD LED BY A COLLEAGUE HAD STOOD UP A PANEL ON IODINE NUTRITION AS PART OF THEIR BIOMARKERS OF NUTRITION AND DEVELOPMENT OR BOND PROGRAM. THESE REPORTS WERE PUBLISHED AND WE HAD A SERIES OF ROUNDTABLE MEETINGS THAT TOOK A MUCH DEEPER DIVE INTO THE METHODOLOGY AND WE PUBLISHED A SYMPOSIUM ISSUE OF 14 PAPERS WHICH LAID OUT WHAT NEEDED TO BE DONE WITH ALL KINDS OF RESEARCH QUESTIONS AND RESEARCH RESOURCE NEEDS. AFTER THAT WITH GOT BUSINESS CREE AND OUR IODINE FACT SHEETS AMONG OUR WONDERFUL FACT SHEETS ON SUPPLEMENT INGREDIENTS WERE UPDATED WITH LATEST INFORMATION, PROFESSIONAL AND CONSUMER LEVELS INCLUDING ENGLISH AND SPANISH AND WE ALSO TOOK TO FURTHER DEVELOP DATABASES WHICH COULD BE USED FOR RESEARCH AND USED FOR CLINICAL APPLICATIONS WHETHER ON SUPPLEMENT BOUGHT AL -- BOTTLE LABELS AND SOME SUPPLEMENTS WERE ANALYZED DIRECTLY AND MOST IMPORTANTLY WE STARTED IN VERY IMPORTANT PROJECT TO ADD IODINE TO THE NATIONAL FOOD COMPOSITION TABLE. THOSE WERE RELEASED LAST SUMMER IN 2020 BY THE USDA ON ITS WEBSITE AND WORKED IN COLLABORATION WITH THE FOOD AND DRUG ADMINISTRATION. THERE'S OVER 400 FOODS IN THE DATABASE NOW. WE ALSO WERE ENCOURAGING NIH INVESTIGATORS INITIATED RESEARCH. WE HAD A NOTICE OF SPECIAL INTEREST ENCOURAGING SUBMISSION OF APPLICATIONS ON IODINE IN HUMAN NUTRITION. WE ARE ENHANCING THE NHANS EYE DIE STATUS AND THEY'RE INHERENTLY GOVERNMENTAL AGENCIES AND COLLABORATE WITH COLLEAGUES AT MANY OTHER FEDERAL AGENCIES THE CDC IN ATLANTA, THE FOOD AND DRUG ADMINISTRATION AND OTHER NIH UNITS AND ESPECIALLY THE U.S. DEPARTMENT OF AGRICULTURE TO WORK ON THESE PROGRAMS. SO IN CONCLUSION, CHECK YOUR SALT AND SEE IF IT'S IODIZED AND TAKE A LOOK AT OUR WEBSITE AND THE DETAILED INFORMATION IT HAS AND DR. PEARCE WILL GO FURTHER TO TELL YOU WHY WE CARE ABOUT IODINE. OKAY. CAN YOU SEE THIS? >> IT LOOKS GOOD. >> THANK YOU. SO IT'S A PLEASURE AND HONOR TO BE HERE TODAY. DR. ERSHOW ASKED KNOW DISCUSS WHAT ARE STILL THE UNANSWERED QUESTION AROUND IODINE NUTRITION. SO I WANT TO START BY THINKING OF CONSEQUENCES OF TOO LITTLE AND TOO MUCH IODINE AND WHAT WE DON'T KNOW AND HOW BEST TO ASSESS IODINE STATUS AND SOME KNOWLEDGE WHERE WE'RE GETTING OUR IODINE CURRENTLY IN THE U.S. AND WHAT GROUPS MAY BE AT RISK FOR IODINE DEFICIENCY. FOR CONTEXT IT'S USED TO MAKE THYROID HORMONE. AS FAR AS WE KNOW IT'S THE ONLY USE BUT IT TURNS OUT TO BE IMPORTANT BECAUSE IT'S ESSENTIAL FOR REGULATING METABOLISM AND DEVELOPMENT. WE'VE KNOWN FOR DECADES SEVERE IODINE DEFICIENCY IS ASSOCIATED WITH A SPECTRUM OF ADVERSE CONSEQUENCES. IT CAN CAUSE HYPOTHYROIDISM AND GOITER OR THYROID ENLARGEMENT BUT THE LARGEST LIST OF ADVERSE AFFECTS IS WHEN THERE'S INADEQUATE INTAKE IN PREGNANCY AND THERE'S INCREASED RISK FOR MISCARRIAGE AND STILL BIRTH AND ANOMALIES AND INFANT AND MATERNAL MORTALITY AND TRAGIC SYNDROMES KNOWN AS CREEDINISM AND THE BIGGEST IMPACT IS IT LOWERS I.Q. AT THE POPULATION LEVEL. WE'VE SEEN THAT FROM A NUMBER OF META ANALYSIS THAT HAVE LOOKED AT REGIONS OF MODERATE TO SEVERE IODINE DEFICIENCY AND DEMONSTRATED PROBABLY A 7 POINT INCREASE IN MEAN I.Q. IN POPULATIONS WHERE THERE'S IODINE SUPPLEMENTATION FOR IODINE DEFICIENCY PREGNANT WOMEN AND SOME FEAR IT MAY BE AS MUCH AS 12 POINTS IN REGIONS SEVERELY IODINE DEFICIENT AND THERE'S BEEN IMMENSE STRIDES IN PUBLIC HEALTH AND NUTRITION MOSTLY DUE TO FORTIFICATION AND WE REMAIN CONCERNED ABOUT IODINE NUTRITION BECAUSE I TOLD BUT PREGNANT WOMEN HAVE THE MOST SEVERE CONSEQUENCES THAN THE REST US AND YOUNG CHILDREN WHEN IODINE NUTRITION IS INADEQUATE AND PREGNANT WOMEN NEED MORE IODINE TO MAINTAIN THYROID FUNCTION AND WOMEN NEED MORE IODINE TO MAKE THYROID HORMONE AND ALSO LOSING MORE IN THE URINE. WOMEN BREAST FEEDING CONTINUE TO NEED HIGHER IODINE INTAKES THAN THE AVERAGE ADULT BECAUSE IT'S ACTIVELY SECRETED INTO BREAST MILK WHERE IT'S AN IMPORTANT NUTRITIONAL SOURCE OF THE CHILD. IF WE LOOK AT THE MAP FOR IODINE STATUS SPECIFICALLY IN PREGNANT WOMEN THIS LOOKS QUITE DIFFERENT THAN THE OVERALL GLOBAL MAP AND IT'S BUILT BY THE WORLD HEALTH ORGANIZATION AND NETWORK BASED ON DATA FOR IODINE SUFFICIENT OF SCHOOL AGED CHILDREN BUT IN MANY PARTS OF THE WORLD WHERE THERE'S IODINE UNAVAILABLE YOU SEE LARGE REGIONS WHERE FIRST WE DON'T HAVE ANN DATA AT ALL OR WHERE DATA ARE SUB NATIONAL AND IT'S ABOUT REGIONS HATCHED AND WE SEE A WHOLE LOT MORE IODINE DEFICIENCY WHERE WE SEE DATA IN THE U.S. AND WESTERN EUROPE. IT'S NOT NECESSARILY A PROBLEM OF THE DEVELOPING WORLD. EVEN MILD TO MODERATE IODINE DEFICIENCY WHICH IS WHAT WE EXPECT IS HAPPENING IN MANY PLACES MAY HAVE ADVERSE AFFECTS ON CHILD BRAIN DEVELOPMENT. ABOUT WHAT WAS NOTED IN THIS COHORT STUDY PUBLISHED IN LANCET IN 2013 WHEN THEY DETERMINED IODINE LEVELS WERE ASSOCIATED WITH CHILD I.Q. AND THEY NOTED THERE SEEMED TO BE DECREASES IN VERBAL AND TOTAL I.Q. AND READING COMPREHENSION NOT JUST IN CHILDREN OF WOMEN WITH SEVERE IODINE DEFICIENCY BUT EVEN IN THE CHILDREN OF THE WOMEN WHO ONLY SEEMED TO HAVE FAIRLY MODEST LEVELS OF IODINE DEFICIENCY AND THIS HAS BEEN SUBSEQUENTLY SEEN IN OTHER OBSERVATIONAL COHORTS. SO BASED ON DATA FOR WHAT WE THINK IS FAIRLY WIDESPREAD, IODINE DEFICIENCY IN COUNTRIES THAT ARE OVERALL IODINE SUFFICIENT AND IT MAY IMPAIR FETAL BRAIN DEVELOPMENT, THERE ARE NOW A NUMBER OF ORGANIZATIONS THAT HAVE MADE RECOMMENDATIONS RECOMMENDING IODINE SUPPLEMENTATION SPECIFICALLY PRECONCEPTION, IN PREGNANCY AND LACTATION. HOWEVER, THOUGH WE HAVE THE RECOMMENDATIONS OUT THERE AND I HELPED DRAW SOME RECOMMENDATIONS IN LIGHT OF CURRENT EVIDENCE IT'S THE RIGHT THING TO DO, EVIDENCE BASE IS FAIRLY WEAK. NOW NOTED IN THE SYSTEMATIC REVIEW AND META-ANALYSIS WHICH LOOKED AT OUR DATA FOR UNDERSTANDING ASSOCIATIONS BETWEEN MILD TO MODERATE IODINE DEFICIENCY AND CHILD DEVELOPMENT OUTCOMES AND FOUND THE EVIDENCE BASE NOT REALLY THERE. THERE ARE THREE RANDOMIZED CLINICAL TRIAL LOOKED AT THE QUESTION WHETHER SUPPLEMENTATION OF MODERATELY DEFICIENT IODINE WOMEN AFFECT CHILDREN AND THE POWERED TRIAL WAS PROBABLY NOT DONE AMONG WOMEN TRULY IODINE DEFICIENCY. THOUGH WE DON'T HAVE DATA OF THE STRATEGY BEING ADVOCATED WE ALSO REALLY HAVEN'T HAD THE RIGHT TRIALS AND THIS IS THE OUTCOME OF THE ANALYSIS AND THE MAJOR CONCLUSION THAT CAME FROM THE SERIES OF ODS ROUNDTABLES HELD SEVERAL YEARS AGO. THERE'S PROBABLY A U-SHAPED RELATIONSHIP IN ADDITION TO HAVING IMPAIRED THYROID PRODUCTION IN DEFICIENCY IT'S PROBABLY IMPAIRED IN IODINE EXCESS. WE HAVE OBSERVATIONAL STUDY SUGGESTING WOMEN WITH BOTH HIGH AND LOW IODINE INTAKES BASED ON THEIR URINARY IODINE CONCENTRATIONS MAY BE AT HIGHER RISK FOR MILD HYPOTHYROIDISM AND TOO LITTLE THYROID HORMONE IN PREGNANCY AND WE DON'T REALLY KNOW THE SAFE LEVELS FOR PREGNANT AND LACTATING WOMEN. AND THE QUESTION DOES IT MAKE SENSE TO SUPPLEMENT MILDLY DEFICIENT IODINE WOMEN WITH SUPPLEMENTS AND WHAT IS THE APPROPRIATE TIME DO WE NEED TO INITIATIVE PRE CONCEPTION OR EARLY PREGNANCY? HOW DO WE BEST DECIDE WHAT DOSE IS APPROPRIATE FOR WHAT WOMEN OR IN WHAT REGIONS? AND SPECIFICALLY IF YEAR INTERESTED IN THE AFFECTS OF IODINE DEFICIENCY AND BRAIN DEVELOPMENT ARE THERE PARTICULAR TOOLS FOR ASSESSING BRAIN DEVELOPMENT IN CHILDREN THAT MAY BE LINKED TO IODINE STATUS AND THYROID STATUS. ANOTHER KEY QUESTION THAT REMAINS RELATIVELY UNRESOLVED IS AGAIN HOW MUCH IODINE IS TRULY EXCESSIVE IN VULNERABLE POPULATIONS. UPPER LIMITS HAVE BEEN SET AT DIFFERENT PLACES AROUND THE WORLD. WE DON'T REALLY HAVE GOOD ANSWERS FOR THIS AND MANY QUESTIONS AND SOME MAY ADVERSELY IMPACT UTILIZATION FOR HORE SYNTHESIS AND THE DISRUPTORS MAY PLAY A ROLE. THIS WORLD HEALTH ORGANIZATION PROVIDED A THRESHOLD VALUES FOR WHAT IS OPTIMAL IODINE NUTRITION OR INADEQUATE IODINE NUTRITION BASED ON MEDIAN URINARY MODELS IN SCHOOL AGED AND LACTATING WOMEN. AND THESE ARE NOT WORKED OUT IN BREAST FEEDING. MACHINE IS SECRETED IN BREAST MILK AND URINE SO NOT SURE HOW TO MEASURE BREAST MILK IODINE AND UNDERSTAND THRESHOLDS THERE. IT'S NOT AN INDIVIDUAL BIOMARKER. WE ALL HAVE HOUR TO HOUR WITH CONCENTRATIONS WHICH MEANS I CAN'T AS A CLINICIAN HAVE A PATIENT IN MY OFFICE TO DIAGNOSE THE IODINE STATUS BASED ON THE METRIC AND CAN LOOK ONLY AT THE POPULATION LEVEL. COULD THERE BE A STATUS TO TAYLOR RECOMMENDATIONS AND HOW CAN WE ASSESS IODINE LACTATION AND NUTRITION AND OTHER BIOMARKERS THAT MAY BE HELPFUL AND WE'RE USING A THYROID PROTEIN IN SOME INTERNATIONAL STUDIES BUT STILL LEARNING HOW TO DEFINE THRESHOLDS FOR THE METRIC AND QUESTIONS ABOUT SERUM OR SALIVA OR BREAST MILK IODINE AND WHAT IT MEANS AT THE INDIVIDUAL OR POPULATION LEVEL. AND THEN FINALLY, THINKING ABOUT DIETARY IODINE IN THE U.S. ABBY ALREADY POINTED OUT 100 YEARS AGO THE U.S. WAS PROFOUNDLY IODINE DEFICIENT AND THAT WENT AWAY WITH THE ADVENT OF IODINE SALT IN THE 1920s. IN RECENT DECADES, THE U.S. OVERALL HAS BEEN CONSIDERED IODINE SUFFICIENT THOUGH WE'VE HAD A HUGE DROP IN THE IODINE INTAKE SINCE THE 1970s. WE HAVE ENE A RE-EMERGENCE OF IODINE DEFICIENCY. THIS IS DATA FROM A SMALL MICHIGAN COHORT WE ANALYZED RECENTLY TAKING ADVANTAGE OF HAVING REPEATED URINARY IODINE MEASURES TO REDUCE THE INDIVIDUAL VARIATION AND WHAT WE WERE ABLE TO SAY BASED ON THE ANALYSIS IS THAT ALTHOUGH THE GROUP OVERALL WAS IODINE INEFFICIENT PROBABLY A QUARTER OF THE WOMEN WERE NOT GETTING ADEQUATE IODINE INTAKES AND WE DON'T KNOW WHETHER THIS IS DATA REPRESENTATIVE ACROSS THE BROADER U.S. P. WE DON'T REALLY KNOW WHICH PREGNANT WOMEN AND AREAS AND GROUP ARE AT HIGHER RISK FOR HAVING INADEQUATE IODINE NUTRITION. YOU HEARD ABOUT IODIZED SALT ALREADY IMPORTANT FOR REDUCING THE GOITER BELT BUT WE NEVER MANDATED THAT IN THE COUNTRY. WE SUSPECT MOST SALTS TAKEN IN IN THE DIET OF AMERICANS CURRENTLY NOT ACTUALLY IODIZED AND NOT SURE HOW BIG OF A ROLE IT'S PLAYING IN AND PROBABLY OUR BIGGEST SOURCE OF IODINE NUTRITION RIGHT NOW IS FROM DAIRY FOODS. WE KNOW THERE'S SOME REGIONAL VARIATION AND PROBABLY SOME SEASONAL VARIATION IN MILK IODINE INTAKES THAT PROBABLY IMPACTS POPULATION STATUS. WE KNOW IN ADDITION, SOME OF THE IODINE THAT IS IN MILK IS THERE USE TO THE WORK OF CLEANSERS BY THE DAIRY INDUSTRY AND OTHER NON-IODINE CONTAINING CLEANSERS OUT THERE. IT'S NOT REALLY A MONITORED OR REGULATED SOURCE OF IODINE IN THE POPULATION AND IT'S POSSIBLE THAT WE COULD SEE BIG SHIFTS WITHOUT BEING AWARE OF IT BECAUSE WE'RE SORT OF RELYING ON A SOMEWHAT FRAGILE SOURCE. WE HAVE RECOMMENDATIONS I'VE TOLD YOU ABOUT IODINE SUPPLEMENTATION IN PREGNANCY AND PRECONCEPTION AND LACTATION AND THERE'S A SMALL NUMBER OF PREGNANT WOMEN IT LOOKS LIKE UPTAKE IN THE SUPPLEMENT OF THOSE WHO NEEDS IT MOST SEEMS TO BE FAIRLY LOW. I'LL FINISH WITH A FEW KEY QUESTIONS HERE. WHAT ARE THE CURRENT KEY SOURCES OF IODINE NUTRITION AND WHICH GROUPS IN THE U.S. ARE AT RISK FOR IODINE DEFICIENCY. DOES IT VARY BY GEOGRAPHY OR LIFE STAGE OR PEOPLE WHO ARE VEGAN OR LACTOSE INTOLERANT AND THOSE WILL BE HAVE TO BE ANSWERED FOR POLICY QUESTIONS SHOULD WE MANDATE OR LOOK AT MILK SUBSTITUTES FOR PEOPLE WHO DON'T HAVE DAIRY? OVERALL ARE WE RECOMMENDED THE RIGHT STRATEGY FOR PREGNANCY AND LACTATION AND ARE THERE BETTER WAYS TO IMPLEMENT IT OR TARGET IT? AND I WAS ASKED TO FINISH WITH A PLUG THAT ODS [AUDIO DIGITIZING] IT'S AN AREA THAT NEEDS INPUT FROM THE ACADEMIC COMMUNITY AS WELL AS FROM GOVERNMENT. WITH THAT I'LL THANK YOU FOR YOUR ATTENTION. >> THANK YOU, DR. PEARCE. THAT WAS A VERY STIMULATING AS WELL AS INFORMATIVE. THANK YOU. OKAY. THE NEXT INITIATIVE WE'RE GOING DISCUSS IS THE NEWEST ODS INITIATIVE THAT IS THE RESILIENCE PROGRAM. I'M GOING TO TURN IT OVER TO MY COLLEAGUE, DR. LAVERNE BROWN A PROGRAM DIRECTOR IN ODS WHO HAS BEEN LEADING THIS INITIATIVE. GO AHEAD, LAVERNE. >> THANK YOU, PATRICIA. AGAIN, MY NAME IS LAVERNE BROWN. I LEAD THE RESILIENCE AND HEALTH STUDIES PROGRAM. I WILL SHARE MY SLIDES JUST SHORTLY. I LEAD THE RESILIENCE HEALTH STUDIES PROGRAM WITH MY COLLEAGUES, DR. DOCTORS COSTELLO AND BARBARA COHEN. THE RESILIENCE AND HEALTH STUDIES PROGRAM IS ONE OF THE NEW INITIATIVES AT THE OFFICE OF DIETARY SUPPLEMENTS ESTABLISHED TO STUDY SCIENCE AND RESILIENCE TO HELP GAIN A BETTER UNDERSTANDING OF RESPONSES TO BIOLOGICAL AND ENVIRONMENTAL AND PSYCHOSOCIAL STRESSORS MAY IMPACT NUTRIENT STATUS AND OVERALL HEALTH STATUS IN INDIVIDUAL. FOR EXAMPLE, THERE'S KEY QUESTIONS WE HOPE WE CAN DRESS INCLUDING WHEN TO CHANGE A NUTRIENT STATUS OR BIOMARKERS REPRESENT ADAPTATION VERSUS A DETRIMENTAL IMBALANCE TO THE SYSTEM OR BOTH AND WHETHER IS THERE A NEED FOR INTERVENTION. THE RESILIENCE AND HEALTH STUDIES PROGRAM MAY HELP GAIN A BETTER INFORMATION OF THE IMPACT AND PROTECTIVE FACTORS HAVE ON DISEASE RISK FACTORS. TO ACHIEVE THESE GOALS, WE STRIVE TO COORDINATE ACTIVITIES AMONGST NIH INSTITUTES, CENTERS AND OFFICES FOR THE PURPOSE OF FOSTERING COLLABORATIONS THAT MAY HELP TO ADVANCE SCIENCE AND RESILIENCE. WE ALSO STRIVE TO HARMONIZE AND INTERRUPT COMMON DATA SETS TO IMPROVED CHARACTERIZATION OF HEALTHY INDIVIDUALS AT BASELINE AS WELL AS LONG-TERM OUTCOMES AND STRIVE THE DEVELOPMENT OF RESEARCH TOOLS AND RESOURCES TO HELP ADVANCE THE SCIENCE OF RESILIENCE. THROUGH OUR EFFORTS TO FACILITATE THE COORDINATION AND HARMONIZATION OF A RESILIENCE RESEARCH AGENDA ACROSS NIH, IN 2019 THE TRANS-NIH RESILIENCE WORKING GROUP WAS ESTABLISHED. THERE WERE OTHER INSTITUTES AND OFFICES AND CENTERS FROM ACROSS NIH. THE GROUP HAS WORKED TO HARMONIZE THE CONCEPT AND RESULTED IN A CONCEPT MODEL OF RESILIENCE AS WELL AS AN OPERATIONAL DEFINITION OF RESILIENCE WHICH STATES, RESILIENCE ENCOMPASS THE CAPACITY TO RESIST, ADAPT TO, RECOVER OR GROW FROM A CHALLENGE. OTHER EFFORTS OF THE RESILIENCE PROGRAM INCLUDE THE RESILIENCE SCIENTIFIC WORKING GROUP. IT WAS ESTABLISHED AS AN EXTENSION OF A TRANS-NIH WORK GROUP TO ADVANCE THE RESEARCH ACROSS THE PROGRAMS AND THE INTRAMURAL RESEARCH AND PARTNERING AGENCIES. THE RESILIENCE RESEARCH MEETS MONTHLY TO PROVIDE INPUT AND COLLABORATION TOWARDS THE DEVELOPMENT OF SYSTEMS OF USE RESULTING INPUT AND SHARED RESOURCES OF DATA WILL BE COLLECTED, STORED AND COLLATED. TO FURTHER FACILITATE HARMONY ACROSS RESILIENCE RESEARCH INVESTIGATIONS, MY COLLEAGUES AND I IN COLLABORATIONS WITH THE TRANS-NIH RESILIENCE WORKING GROUP DEVELOPED THE DECISION TOOL. THE TOOL PROVIDE GUIDANCE ON BEST PRACTICES FOR DESIGNING STUDIES INTENDED TO TARGET RESILIENCE OUTCOMES. THESE AND OTHER RESOURCES CAN BE ACCESSED VIA THE RESILIENCE WEB PAGE POSTED ON THE OFFICE OF DIETARY SUPPLEMENTS WEBSITE. I SPOKE ABOUT THE COORDINATING ACTIVITIES OF THE RESILIENCE PROGRAM BUT YOU'RE LIKELY CURIOUS ABOUT MORE OF THE RESILIENCE RESEARCH INTO THE OFFICE OF DIETARY SUPPLEMENTS. THE OFFICE OF DIETARY SUPPLEMENTS IN COLLABORATION WITH PARTNERING AGENCIES AND OTHER INSTITUTES AND CENTERS SUPPORTS RESILIENCE RESEARCH BY FUNDING INTERAGENCY AGREEMENTS, SIGNING GRANTS AND ADMINISTRATIVE SUPPLEMENTS AND CO-FUNDING OPPORTUNITIES. PROVIDE HERE SAY SNAPSHOT OF ODS FUNDED RESILIENCE RESEARCH FROM 2018 TO 2020. YOU CAN SEE FROM THE EXAMPLES THAT NIH HAS COLLABORATED OR THE NIH OFFICE OF DIETARY SUPPLEMENTS HAS COLLABORATED WITH A WIDE RANGE OF INSTITUTES AND CENTERS ON RESILIENCE THAT COVER A WIDE RANGE OF DIETARY SUPPLEMENTS AND INGREDIENTS. I'D LIKE TO ESPECIALLY HIGHLIGHT COLLABORATIONS FOR THE CONSORTIUM OF CHAMP. ODS ENJOYED A LARGE RELATIONSHIP WITH CHAMP INCLUDING DIETARY INGREDIENTS TO MINIMIZE ENVIRONMENTAL INJURY. I'M PLEASED THE DIRECTOR OF CHAMP IS THE NEXT SPEAKER AND HAS AGREED TO PROVIDE AN OVERVIEW OF SOME OF THOSE FRUITFUL COLLABORATIONS. DR. DEUSTER IS THE DEPARTMENT OF MILITARY AND EMERGENCY MEDICINE AND CHIEF SCIENCE OFFICER FOR THE CONSORTIUM OF HEALTH AND MILITARY PERFORMANCE AND HAS WORKED ON HUMAN PERFORMANCE MORE THAN 25 YEARS. SHE'S A FELLOW OF AMERICAN COLLEGE OF SPORTS MEDICINE AND CERTIFIED NUTRITION SPECIALIST AND HAS MORE THAN 300 PEER-REVIEWED PAPERS AND BOOKS RELATING TO HEALTH AND MILITARY NUTRITION. WITH THAT, I'D LIKE TO WELCOME DR. DEUSTER TO THE PANEL. >> THANK YOU FOR THE INVITATION TO TALK AND CONGRATULATIONS ON 25 YEARS AND DR. BROWN MENTIONED THE CONSORTIUM FOR HEALTH AND MILITARY PERFORMANCE. I WAS THE EXECUTIVE DIRECTOR FOR YEARS AND I JUST STEPPED DOWN ABOUT TWO MONTHS AGO SO THERE COULD BE SOME NEW YOUNG LEADERSHIP AND I AM NOW THE CHIEF SCIENCE OFFICER. BUT WHAT IS THE CONSORTIUM FOR HEALTH AND MILITARY PERFORMANCE. SHE SAID IT WAS A DOD CENTER OF EXCELLENCE. WE CONDUCT RESEARCH AND TRANSLATE IT AND DISSEMINATE IT FOR MILITARY MEMBERS. THE GOAL IS FOR TOTAL COURSE FITNESS AND HUMAN PERFORMANCE OPTIMIZATION. IT'S AKA RESILIENCE. WE WANT OUR MILITARY MEMBERS AND SERVICE MEMBERS TO BE AS RESILIENT AS THEY POSSIBLY CAN BE. THIS IS A SNAPSHOT THAT SHOWS THE ORGANIZATION. WE'RE WITHIN THE UNIFORM SERVICES UNIVERSITY HEALTH SCIENCES A DOD HEALTH SCIENCES UNIVERSITY AND HAVE LEADERSHIP, RESEARCH AND EDUCATION. I WOULD BE REMISS IF I DIDN'T MENTION OUR TWO EDUCATIONAL WEBSITES HUMAN PERFORMANCE WEBSITES WHERE THERE'S LOTS OF INFORMATION ON TOTAL FORCE FITNESS AND THE DOD RESEARCH FOR SUPPLEMENTARY SUPPLEMENTS. MILITARY MEMBERS USE MORE DIETARY SUPPLEMENT THAN ANY OTHER POPULATION AND THEY DO IT BECAUSE THEY WANT TO BE READY FOR THEIR ADVERSARY. WE ALWAYS PARTNER WITH THE OFFICE OF DIETARY SUPPLEMENTS FOR INFORMATION TO MAKE SURE WE'RE NOT DUPLICATIVE. THE WEBSITE IS OPSS.org AND A GREAT SOURCE FOR SERVICE MEMBERS AND CIVILIANS GO THERE AS WELL. WHAT COULD I MEAN TO OPTIMIZE PERFORMANCE? IN TERMS OF OUR SERVICE MEMBERS WE WANT THEM TO BE THE BEST THEY POSSIBLY CAN AT THE TASKS RELATED THEIR CAREER FIELD OR THEIR OCCUPATION SO WE WANT TO BUILD RESILIENCE. WE ALSO WANT TO BE WHAT WE CALL LEFT WHERE THE SERVICE MEMBER IS ALWAYS PREVENTING OR REDUCING THE OPPORTUNITY FOR AN ADVERSE EVENT. WE WANT TO PREVENT IL WE WANT TO ENSURE RESILIENCE. RESILIENCE IS A MESSAGE AND THIS CAME ABOUT IN THE DEPARTMENT OF DEFENSE IN 2009 AND IS A HOLISTIC WAY OF LOOKING AT THE SERVICE MEMBER AND THEIR FAMILY, THEIR UNIT AND THE ORGANIZATION. WE LOOKED AT THEM FROM THE ENTIRE PERSPECTIVE. AGAIN, IT'S A WHOLISTIC AND ABOUT EVERYTHING WE DO LOOKS AT IT FROM THIS LENS. AGAIN, IT'S ABOUT RESILIENCE. THIS IS ANOTHER CARTOON WE USE ACROSS THE DEPARTMENT OF DEFENSE THAT SHOWS THE SPECTRUM OF HUMAN PERFORMANCE. IF YOU SEE THE RED AND ORANGE IS USUALLY WHEN YOU'RE TRYING TO RECOVER FROM SOMETHING AND AS YOU MOVE FROM THE ARROW YOU SEE OCCUPATIONAL OR UNIT ESSENTIAL MISSION TASK LIST AND WHAT THEY HAVE TO DO FOR THEIR JOB? WE ALWAYS TRY TO BUILD RESILIENCE FOR PERFORMANCE SUSTAINMENT AND ENHANCEMENT. THOSE ARE KEY ISSUES AROUND THE DEPARTMENT OF DEFENSE AND SO HOW DO WE FRAME RESILIENCE RESEARCH? FIRST WE NEED A STRESSOR OR CHALLENGE AS MENTIONED AND THOSE CAN BE VARIETAL, METABOLIC, PHYSICAL OR PSYCHOLOGICAL OR EMOTIONAL. THEN YOU HAVE TO HAVE MODELS FOR THE RESILIENCE RESEARCH. CAN HAVE ALL THESE STUDIES AND WE HAVE TO APPLY AN INTERVENTION. THE INTERVENTION WILL AFFECT MULTIPLE SYSTEMS. IN THE END WE LOOK AT OUTCOMES. IS THAT HEALTH MAINTENANCE OR SURVIVORSHIP OR MAYBE WE'RE LOOKING AT MECHANISMS, PREVENTION OR POTENTIALLY PROTECTION. BUT IN THE LONG RUN WHAT WE'RE TRULY DOING IS ASKING THE QUESTION IS IT GOING TO CONFER RESILIENCE OR OUR ABILITY TO ADAPT OR GROW FROM A PARTICULAR CHALLENGE. SOW CHAMP AND ODS HAVE HAD COLLABORATIONS AND I HIGHLIGHTED THOSE THEY PARTICIPATED IN AND I'LL GO OVER SOME OF THE PROJECTS TODAY. I'LL START WITH WHAT I CALL SYSTEMATIC REVIEWS. THE FIRST TWO, DIETARY INGREDIENTS IS AN ALTERN TICH APPROACH FOR MITIGATING MUSCULOSKELETAL PAIN AS SOMETHING THAT CAME OUT IN SPECIAL OPERATIONS COMMAND BECAUSE IT'S ONE OF THE LEADING CAUSES OF DISABILITY IS PAIN FROM MUSCULOSKELETAL DISORDER AND WHEN BRAIN HEALTH PRODUCTS BECAME REALLY COMMON IN THE MARKETPLACE, WE DID ANOTHER SYSTEMATIC REVIEW FOR INGREDIENTS THAT COULD POTENTIALLY BE USED FOR OPTIMIZING COGNITIVE PERFORMANCE FOR BRAIN HEALTH AMONG HEALTHY ADULT. AND THE LAST ONE, DIETARY SUPPLEMENT INGREDIENTS FOR PRESERVING AND PROTECT THE IMMUNE SYSTEM AS AN ONGOING PROJECT THAT WE'RE COLLABORATING AND BEING FUNDED BY THE OFFICE OF DIETARY SUPPLEMENTS. I WON'T MENTION THAT AGAIN BECAUSE IT'S IN ITS NASCENT STAGE. ODS IS ALWAYS ON OUR EXPERT PANELS AARE OTHER FOLKS FROM ACROSS THE NATION. WE GATHER STAKEHOLDER INPUT WHEN WE DO A SCOPING REVIEW OF WHAT EXISTS AND WE ALSO DO A QUALITATIVE AND QUANTITATIVE ANALYSIS USUALLY OF SELECT PRODUCTS AND THEY EMERGE BECAUSE SERVICE MEMBERS ARE TALK ABOUT THEM. WE LOOK AT THE EVIDENCE AND CRITICALLY EVALUATE IT AND THE INGREDIENTS AND AFTER ALL THAT INFORMATION IS PUT TOGETHER WE CONVENE OUR PANEL TO TALK WITH THE STATE OF THE SCIENCE AND LOOKED AT THE EVIDENCE. WHEN WE'RE DONE AND WE LOOKED AT COST AND FEASIBILITY. THE EXPERT PANEL DRIVES WHAT THE RESULT AND PUBLISH FINDINGS IN PEER-REVIEWED JOURNALS AND ALSO DEVELOP EDUCATIONAL MATERIALS FOR WIDE REACH TYPICALLY AMONG OUR SERVICE MEMBERS BECAUSE THEY NEED TO KNOW WHAT THEY SHOULD AND SHOULDN'T BE DOING. WE FINISHED UP UP ONE ON BRAIN HEALTH AND WE HAVE TO IDENTIFY WHAT OUR POPULATION IS AND YOU CAN SEE WHAT IT IS RIGHT THERE. THEN LOOKED AT THE INTERVENTION AND LOOKED AT THE LITERATURE FOR THE INGREDIENTS ADMINISTERED AND WHAT ARE OUTCOMES [AUDIO DIGITIZING] THERE WERE SO MANY TYPES OF TESTS COULD HAVE BEEN A SYSTEMATIC REVIEW AND TIMING STUDY DESIGN. ONE OF THE OTHER PIECES I'M GOING SHARE WITH YOU THIS IS A SUMMARY AND AND WE ALWAYS WEIGH THE EVIDENCE OR WHAT WE DO FOR THE REVIEWS WE PUBLISH IT IN THE PEER-REVIEWED LITERATURE AND THIS IS AN EXAMPLE OF THE SOME OF THE ONES WE'VE DONE. PUBLICATIONS AND WE ALSO HAD THE DEPARTMENT OF DEFENSE AND THEY CAN LOOK AND SEE WHAT THE EVIDENCE SAYS ABOUT BRAIN HEALTH. SO MUSCULOSKELETAL PAIN AND I TALKED ABOUT THAT AND THERE WERE A NUMBER OF PUBLICATIONS THAT EMERGED. AGAIN, BASED ON THE SCIENCE AND EDUCATIONAL MATERIALS FOR OUR SERVICE MEMBERS. SO FIELD TRIAL THIS IS SOMETHING WE PUBLISHED IN 2001. IT WAYS POPULAR SUPPLEMENT AND DOES CREATINE IMPROVE PERFORMANCE AND WE LOOKED AT TASKS. WE LOOKED AT WHAT IS OUR PRIMARY ENVIRONMENTAL STRESSOR. AND WHY IS THIS IMPORTANT? WELL, THERE'S A LOT OF HEAT INJURY IN THE MILITARY DUE TO EXERCISE AND TAKING THERMO GENIC AGENTS. AND THERE'S A FEDERAL WORKING GROUP LOOKING AT CLIMATE CHANGE AND NUTRITION. MAYBE THESE ARE SOME THINGS WE NEED TO LOOK AT IN TERMS OF PHYSIOLOGICAL HEAT. THIS IS A CLINICAL TRIAL WE DID A NUMBER OF YEARS AGO AND PUBLISHED IT THERMAL BIOLOGY AND PHYSIOLOGIC STRAIN AND ONE PIECE OF DATA THERE WERE FOUR GROUPS AND PLACEBO AND WHAT WE FOUND WAS THERE WAS NOT AN ADEQUATE AFFECT AND ENDED UP INCREASING RECTAL TEMPERATURE UNDER BOTH CONDITIONS. AND THEREFORE YOU HAVE TO BE CONCERNED ABOUT TAKING CAFFEINE IN THE HEAT THAT WILL INCREASE THE TEMPERATURE. SO WE SAID MECHANISMS. HOW DO WE UNCOVER MECHANISMS? WHAT WE FOCUS IN ON OUR LAB ARE THE MITOCHONDRIAL WHAT HAPPENED TO THE MITOCHONDRIA. IT'S IMPORTANT FOR BASIC CELLULAR PATHWAYS AND PROCESSES. BIO SYNTHETIC PROCESSES AND CELL SIGNALLING AND REDOX STATUS AND ANTIOXIDANT DEFENSE AND APOPTOSIS. WE HAVE LOOKED AT THE MECHANISMS OF MITOCHONDRIA. WHAT YOU HAVE OVER HERE IS A STRESSOR ENVIRONMENTAL AND EMOTIONAL AND METABOLIC OR PSYCHOSOCIAL AND RESILIENCE OR STRESS VULNERABILITIES. WE LOOKED AT MITOCHONDRIAL NOT ONLY THE POTENTIAL BUT FISSION AND FUSION AND A HIGH PROLONGED STRESS WILL LEAD TO FRAGMENTATION OF MITOCHONDRIA WHEREAS LOW SHORT INTENSITY MAY RESULT INFUSION OR ELONGATION OF MITOCHONDRIA. THAT IS SOME OF THE BASIC SCIENCE WORK TO LOOK AT MECHANISM. I'LL GO THROUGH A FEW SLIDES. I WON'T PAY A LOT OF ATTENTION TO THE DATA PER SE BUT MODELS. WE USED MOUSE CELL LINES AND EXPOSED THEM TO 37 DEGREES C OR 43 DEGREES C AND ADMINISTERED DIFFERENT DIETARY INGREDIENTS. I'M SHOWING A COUPLE OF THE ONES WE'VE USED IN OUR CELL CULTURE STUDIES IN PARTICULAR CUMIN AND THE OTHER AND LOOK IF THEY PRESERVE AND LOOKED AT THE BALANCE TOWARDS FUSION. THAT'S ONE EXAMPLE OF HOW WE USED CELL CULTURES TO LOOK AT MECHANISMS. WE DON'T WANT TO STICK WITH CELL CULTURES AND I'M GOING FROM BIG TO SMALL AND FROM SYSTEMATIC REVIEWS TO CLINICAL TRIALS AND NOW LOOKING AT CELL CULTURE. WE LOOKED AT MICE AND LOOK AT THEIR CORE TEMPERATURE AND HEART RATE AND SO ON AND EXPOSED THEM TO HEAT OR NO HEAT AND ADMINISTERED AN INGREDIENT OR NO INGREDIENT. IN THIS CASE I'M GIVING YOU AN EXAMPLE OF CURCUMIN. AND THEN WE LOOKED AT AFTER AND EXPOSED THEM TO THIS AND WE WILL TAKE THEM AND WILL SACRIFICE THEM AND LOOK AT THEIR MITOCHONDRIA. AND WE LOOKED AT MOUSE SKELETAL MUSCLE. WE FOUND CURCUMIN REDUCED HEAT INDUCED MITOCHONDRIA DAMAGE IN THE SKELETAL MUSCLE. WE HAVE SHAM VERSUS HEAT AND HERE'S JUST SOME PICTURES OF THAT AS WELL. AND THE POINT IS NOT TO HIGHLIGHT NECESSARILY THE DATA BUT RATHER HOW WE CONFUSE THESE TYPES OF CHALLENGES TO LOOK AT RESILIENCE. AND WE LOOKED AT THE MICE HYPOTHALAMUS AND SHOWING THE RESULTS FROM WE DID RESULTS IN THE MOUSE STUDIES AND I'M SHOWING BASIC RESULTS OF ASTAXANTHIN AND LOOKING AND YOU CAN SEE ASTAXANTHIN WHEN INDUCED TO A MOUSE REDUCED APOPTOSIS. IF YOU THINK ABOUT IT, YOU HAVE TO SAY COULD THIS BE TRANSLATED TO A HUMAN STUDY. THE ANSWER IS WE'D LOVE TO DO A CLINICAL TRIAL AND WILL PROPOSE SOMETHING LIKE THAT IN AT THE NEAR FUTURE. SO I'D LIKE TO JUST SUMMARIZE AND I'VE GONE FROM THE BIG PICTURE TO THE LITTLE PICTURE AND THIS IS KIND OF A VIM FOR RESILIENCE RESEARCH. YOU CAN USE A SYSTEMATIC REVIEW TO LOOK AT THE EVIDENCE AND WHERE ARE THE GAPS. YOU CAN LOOK AT CELL AND ANIMAL STUDIES AND HOW'S THE INVENTION WORK AND LOOK AT THE INVENTION IS IT SAFE AND EFFECTIVE. YOU CAN USE EPIDEMIOLOGIC STUDIES TO LOOK AT CAUSES AND HOW'S IT HAPPEN AND USE EXPERT PANEL TO SEE HOW CAN THE INTERVENTION BE IMPLEMENTED OR WHAT IS NEXT? ALWAYS IN THE CONTEXT OF RESILIENCE. ADAPT, RECOVER AND GROW. I'D LIKE TO TAKE A COUPLE MINUTES TO ACKNOWLEDGE ALL THESE FOLKS HERE. I'D LIKE TO THANK DR. PAUL COATES ON OUR ADVISORY BOARD FOR A LONG TIME AND BECKY COSTELLO WHO I'VE BEEN WORKING WITH PROBABLY 35 AND DR. BETZ AND DR. BROWN AND ANDY LINDSEY AND ALL WHO CONTRIBUTED TO THE WORK. THERE'S FURTHER INFORMATION AND I KNOW WE'LL OPEN IT UP FOR QUESTIONS. >> THAT WAS WONDERFUL THANK YOU. THAT WAS VERY STIMULATING AND INTERESTING PRESENTATION. SO NOW WE ARE ABOUT READY TO BEGIN OUR QUESTION AND ANSWER SESSION. WE HAVE A FEW MINUTES REMAINING. IF ALL THE SPEAKERS IN THE SECTION WOULD TURN THEIR CAMERAS BACK ON, I'D APPRECIATE THAT. THANK YOU. LET ME START WITH ONE QUESTION THAT CAME IN MOST STUDIES SO FAR ARE FOR THE PREVENTION OF DISEASE. HOW CAN THE SUPPLEMENT INDUSTRY BENEFIT IF THE REGULATION PROHIBIT THE USE OF DISEASE STUDIES FOR SUBSTANTIATION? >> OUR FOCUS IS NOT ON DISEASE. IT'S ON RESILIENCE AND HOW DIETARY SUPPLEMENTS MAY IMPACT IT CAN LEAD TO PATHWAYS THAT ARE EFFECTIVELY RESILIENT OUTCOMES. IT CAN GO TO THE OFFICE OF DIETARY SUPPLEMENT. FRANKLY YOU NEED BOTH. WE NEED TO HAVE AN UNDERSTANDING OF THE DISEASE OUTCOMES AS WELL AS THE UNDERSTANDING OF THE RESILIENCE OUTCOMES IN ORDER TO KNOW HOW DIETARY SUPPLEMENTS FIT AND MAKE AN IMPACT. >> THIS IS JOE BETZ THE DIRECTOR OF THE OFFICE. I'LL NOTE THE LEGISLATION WAS WRITTEN BY THE CONGRESS. IT'S TO ADDRESS GENERAL HEALTH AND WELLNESS WHICH IS WHERE RESILIENCE FITS IN. HOW THE SUPPLEMENT INDUSTRY CAN BE BENEFITTED BY DISEASE CLAIMS, DISEASE TREATMENT WORK IS NOT UP TO US. THAT'S UP TO THE CONGRESS. I'M GOING TO PUNT ON THAT ONE AND MAKE A NOTE OF THAT. HOWEVER, SOMETIMES WHEN WE'RE DOING THE MECHANISTIC STUDIES SOME DISEASE RISK REDUCTION WORK EVEN SECONDARY OR TERTIARY DISEASE PREVENTION, WE WILL UNCOVER MECHANISMS THAT MIGHT BE IMPORTANT IN THE DISEASE PROCESS. SO SEVERAL STEPS BEFORE ONE WOULD GET TO DISEASE TREATMENT. SO CONGRESS DECIDED THERE WOULD BE A CATEGORY CALLED DIETARY SUPPLEMENTS NOT FOCUSSED ON DISEASE TREATMENT BECAUSE THERE'S ALREADY A CONGRESSIONALLY CREATED CATEGORY OF PRODUCT FOR DISEASE TREATMENT AND THOSE ARE CALLED DRUGS. SO HAVING SAID THAT, I'LL SIGN OFF AND SEE IF THE PANELISTS HAVE ANYTHING TO ADD. >> ANY OTHER COMMENTS ABOUT THAT ONE? OKAY. HERE'S ANOTHER QUESTION. HOW IS -- THIS IS ALL OF YOURS TODAY, HOW IS OMICS APPLIED TO YOUR PRESENTATION TODAY? LET'S SEE, DR. PEARCE. HOW ABOUT IF I PICK ON YOU FIRST? >> SO I WILL ACKNOWLEDGE THAT MOST OF THE WORK DONE AROUND IODINE NUTRITION IS AT THE LARGER SCALE OF LOOKING AT OUTCOMES RELATED TO THYROID HORMONE AND CHILD BRAIN DEVELOPMENT AND PROBABLY LESS MECHANISTIC THAN MIGHT BE SORT OF ASSESSED THROUGH SOME OF THE OMICS KIND OF APPROACH. I'M NOT AWARE OF THE OMICS APPROACH AND MAYBE THAT'S AN AREA THAT SHOULD BE EXPLORED FURTHER. >> ANY OTHER SPEAKERS? >> WHO WAS THAT ADDRESSED TO? >> DR. TAYLOR. BUT IT WAS RECORDED. DR. DUCESTER. >> WE ARE APPLYING MORE AND MORE TO HEAT AS THE CHALLENGE BECAUSE WE'RE VERY INTERESTED IN LOOKING AT WHAT ARE SOME -- WHAT WOULD IDENTIFY AS SUSCEPTIBILITY AND WHAT ARE SOME PATHWAYS. IT'S A VERY IMPORTANT PIECE OF WHAT WE'RE DOING. THANK YOU. >> I DON'T SEE DR. SEMPOS ON MY SCREEN. I'M NOT SURE IF HE'S IN THE GROUP AT THE MOMENT. DR. BRANNON, HOW ABOUT YOU, ARE YOU WITH US? >> I AM. I WOULD COMMENT THAT I RAISED THE OMICS AS A FUTURE CHALLENGE FOR SYSTEMATIC REVIEWS BECAUSE ESPECIALLY AS WE LOOK CROSS OMICS AND AS WE START LOOKING AT NETWORKS AND SYSTEMS APPROACH USING THE VARIETY OF OMICS. I THINK AS WE THINK ABOUT HOW TO SYNTHESIZE THE TOTALITY AND QUALITY OF EVIDENCE WE'LL FACE REAL CHALLENGES BECAUSE IT'S NOT SORT THEIR TRADITIONAL QUALIFIED SURROGATE OR HEALTH OUTCOME IN A PATHWAY THAT IS HAS BEEN WELL EXAMINED OF SYSTEMIC REVIEWS AND THERE'S METHOD LOGICAL APPROACHES THAT NEED TO BE DEVELOPED AND MAY BE WITH US SOONER THAN WE IMAGINE. >> THIS QUESTION WAS SPECIFICALLY FOR THE RESILIENCE NIRNT -- SPEAKERS. CAN YOU SPEAK ABOUT THE RESILIENCE TOOL KIT? >> THE TRANS-NIH RESILIENCE WORKING GROUP AS WELL AS MY COLLEAGUES AT THE OFFICE OF DIETARY SUPPLEMENT PUT TOGETHER A DECISION TOOL, I THINK IS WHAT YOU ARE REFERRING TO, WHICH YOU CAN USE A DIAGRAM OR A SCHEMATIC TO HELP GUIDE YOUR RESEARCH EFFORTS. SO YOUR RESEARCH DESIGNS. THE GOAL THERE WAS TO TRY TO START HARMONIZING HOW RESILIENCE RESEARCH STUDIES ARE DESIGNED SO THAT THE OUTCOMES CAN BE MORE INTEROPERABLE AND THERE'S KAFTICES OF A RESILIENCE STUDY THAT SHOULD BE CONSIDERED EITHER BEFORE DESIGNING THE STUDY OR REPORTING OUTKOCHLZ. IT WOULD BE GREAT IF THE SCIENCE AND RESILIENCE RESEARCH WOULD START HIGHLIGHTING KEY FEATURES THAT MAKE THE PRODUCT RESILIENCE AND MADE THE PROJECT IMPORTANT FOR DEFINING RESILIENCE. >> WE HAVE BEEN GIVEN PERMISSION TO GO OVER. AND WE LEARNED ONCE THE POPULATION HAS SUFFICIENT IODINE INTAKE PREGNANT WOMEN ARE RECEIVING SUFFICIENT DINE. THE PROBLEM IS THE INDICATOR. WE CONTINUE USING UIC WITH 150 MICROGRAMS PER LITER WITHOUT SCIENTIFIC REPORT AND MOREOVER THE INTERPRETATION IS BASED ON THE MEDIA MAKING IT 50% OR MORE REACH THAT VALUE AND THE POPULATION IS FINE. WE NEED BETTER INDICATORS. THE IODINE AND ABBY, WOULD YOU LIKE TO TAKE THAT QUESTION? >> I WOULD ABSOLUTELY AGREE WE COULD USE BETTER INDICATORS. PART OF THE PROBLEM WITH STUDIES TH -- STUDYING THE AREA IS WE'RE NOT SURE OF WHAT THE THRESHOLD IS AND WHERE WE SHOULD SET THEM AS OPTIMAL AND SOME DATA SUGGESTS THERE IS AND NOT AND THERE'S CONTRADICTORY DATA WHERE IF YOU ANALYZE THE WHOLE POPULATION IODINE INTAKE AND FOR EXAMPLE SCHOOL AGED CHILDREN YOU GET SOME DATA THAT SUGGESTS YES AND NO. IT SORT OF HIGHLIGHTS THERE REMAIN IMPORTANT QUESTIONS IN WHAT I THINK IS AN IMPORTANT AREA OF PUBLIC HEALTH THAT DO NOT HAVE SATISFACTORY INFORMATION. >> THANK YOU. WHAT ARE SOME ENVIRONMENTAL DISRUPTERS THAT AFFECT IODINE STATUS? >> PRECHLORATE FOUND IN MANY FOOD AND WATER SUPPLY IN THE U.S. IS AN INHIBITS THE ABILITY TO BRING IODINE IN THE GLAND AND THIOSINUATE OF CRUCIFEROUS VEGETABLES AND CIGARETTE SMOKE CAN DO THE SAME THING. THERE'S SEVERAL OF THESE ENVIRONMENTAL DISRUPTORS THAT SEEM TO SPECIFICALLY INHIBIT THE ABILITY OF THE THYROID TO UTILIZE IODINE AS AROUND AND IT SUGGESTS IF THE DISRUPTORS ARE PRESENT IN HIGH ENOUGH LEVELS IN THE ENVIRONMENT AND PARTICULARLY IF IODINE INTAKE IS LOW IT CAN IMPAIR THYROID FUNCTION AND IMPAIR CHILD BRAIN DEVELOPMENT. >> THE RESEARCH WE'RE HOPING TO GET INSIGHT FROM THE UPCOMING HANES STUDY WHERE WE'LL BE ABLE TO MAKE ASSESSMENTS OF LIKELY IODINE INTAKE IN RELATION TO THOSE THYROID PANEL MEASUREMENTS AGAIN THAT WILL BE AND IN PREGNANT WOMEN WITH HANES IS IS NOT THE BEST PLACE TO GET A GOOD SIZED POPULATION OF PREGNANT WOMEN FOR A STUDY. THAT'S ANOTHER CHALLENGE WE NEEDS INGENUITY. >> WE SHOULD STOP NOW FOR OUR LUNCH BREAK. IF THERE'S ANY OTHER QUESTIONS THE AUDIENCE HAS THAT HASN'T BEEN ANSWERED, PLEASE DO SEND THEM IN THROUGH THE Q&A SECTION OF THE WEBEX OR BY CONTACTING US THROUGH THE ODS WEBSITE OR SENDING QUESTIONS THROUGH THE E-MAIL AND THAT E-MAIL ADDRESS ODS@NIH.gov. THANK YOU AGAIN EVERYONE. ALL THE SPEAKERS AND PANELISTS AND WE APPRECIATE IT AND WE'LL BE BACK AT THE NEXT SESSION AT 12:55. THANK YOU EVERYONE. THIS AFTERNOON WE'LL BE HIGHLIGHTING MORE ACTIVITIES FROM THE OFFICE OF DIETARY SUPPLEMENTS THAT HELP THE RESEARCH COMMUNITY DO ITS WORK BETTER. AND IT WILL BE HOSTED BY DR. DWYER AND SALDANHA AND DR. BAILEN AND I'LL HAND IT TO DR. DWYER AND YOU'RE GOOD STO GO. -- GOOD TO GO. THANK YOU. >> I'LL DESCRIBE THE DIETARY SUPPLEMENT DATABASE AND THEN TALK ABOUT USING IT AS A PUBLIC HEALTH TOOL AND PLANS FOR THE FUTURE AND THE SHORT VIDEO ON THE MODERNIZED DATA. DIETARY SUPPLEMENTS ARE WIDELY USED. AT LEAST 33% OF KIDS AND THERE'S BIO ACTIVES THAT AFFECT PUBLIC HEALTH. CONSUMERS AND RESEARCHERS NEED A DATABASE. WHAT WE TRIED TO DO OVER THE PAST 10 YEARS WITH THE HELP OF LEILA AND ALSO RICH BAILEN IS TO DEVELOP A DATABASE THAT'S GOT THE INFORMATION I THINK YOU WANT IN ONE PLACE. THERE'S MANY USES FIRST LOOKING UP NUTRIENT SUPPLEMENTS WHICH ARE NECESSARY IN SOME CASES. IDENTIFYING THE INGREDIENTS AND I'LL SHOW YOU SOME EXAMPLES OF THAT AND TOTAL POPULATION INTAKE EXPOSURE ESTIMATES. JUST FOR STARTING OUT, I'M GOING TO FOCUS ON USES AS A PUBLIC HEALTH TOOL BUT WE CAN ALSO DO IT FOR CONSUMERS OR FOR RESEARCH PURPOSES AS WELL. LET'S START WITH PRENATAL DIETARY SUPPLEMENTS BECAUSE MANY WOMEN OF CHILDBEARING AGE DON'T REALLY GET THE NUTRIENTS THEY NEED BEFORE GOING INTO PREGNANCY AND THERE'S BEEN INTERESTING WORK WITH COLLEAGUES AT PURDUE AND WE FOLLOWED IT UP WITH LOOKING AT THE DIETARY SUPPLEMENT ARE PRENATALS AND WE FIND A COUPLE THINGS VERY IMPORTANT. FIRST OF ALL ACID AND FOLIC ACID ARE VERY HIGH AND SUITABLE FOR SOME WOMEN IN DEVELOPING COUNTRIES AND YET MOST U.S. WOMEN AREN'T AT HIGH RISK. SECONDLY, THERE'S A LOT OF RECOMMENDATIONS AND THEY'RE RATHER CONFUSING AND THIRD, THE NEW INGREDIENTS VERY WIDELY VARIES IN AMOUNTS AND IODINE AND EPA, CHOLINE AND SOMETIMES THEY HAVE BOTANICALS IN THEM AS WELL. HERE ONE EXAMPLE. WHEN WE START THE ALL THIS WORK WE THOUGHT ALL SUPPLEMENTS IF THEY'RE PRENATALS WILL CONTAIN FOLIC ACID. WELL, NOT SO. IT TURNED OUT OVER THE YEARS MORE THIS TYPE OF SALT IS APPEARING BY THEMSELVES IN PRESCRIPTION PRENATALS OR IN COMBINATION AND THIS IS AN ISSUE BECAUSE OF BIO AVAILABILITY IS DIFFERENT AND THERE'S THE CONTRIBUTIONS OF SUPPLEMENTS AND POLICY RECOMMENDATIONS. LET ME SHOW YOU SOME DATA FROM COLLEAGUES DOWN IN ATLANTA, CHRISTINE FIEZ -- PFEIFFER AND I LOOKED AT FOLATE INSUFFICIENCY IS STILL PREVALENT IN ABOUT 20% OF WOMEN AND THE WOMEN MOST LIKELY TO BE A LITTLE LOW ARE YOUNG LOWER INCOME WOMEN LEAST LIKELY TO USE PRENATAL SUPPLEMENTS OR ANY SUPPLEMENTS. SO THIS IS A PROBLEM. REGAN BAILEY HAVE DONE INTERESTING WORK LOOKING AT INTAKE OF FOLATE AND IRON AND OTHERS AS WELL IN THESE PRENATALS AND THE PAPER WAS INTERESTING BECAUSE IF YOU LOOK AT THE GREEN CIRCLE THE ESTIMATES OF HOW MANY -- WHAT PERCENT OF WOMEN WERE BELOW THE ESTIMATED AVERAGE REQUIREMENT FOR FOLIC ACID AND THAT OF COURSE IS THE STANDARD WE USE FOR JUDGING DIETARY ADEQUACY. WHAT YOU SEE FOR THE WOMEN WHO USE SUPPLEMENTS IN THE LIGHTER BLUE THE PERCENT OF WOMEN BELOW THAT INDICATOR FELL DRAMATICALLY WHEN THEY USED DIETARY SUPPLEMENTS. FOOD ALONE WASN'T ENOUGH BUT IF THEY ADDED THE PRENATAL SUPPLEMENTS THEY DID MUCH BETTER. SAME WAS TRUE ALSO FOR IRON. SO WHAT WE END UP WITH IS CONCLUDING THAT INCLUDING PRENATAL SUPPLEMENTS DECREASES ADEQUACY DRAMATICALLY BUT IT'S A TWO-EDGED SWORD AND WE HAVE TO BE CAREFUL ABOUT AMOUNTS. HERE'S THE REASON. THEY ALSO SHOWED THEM THE SAME ARTICLE AT ABOUT 40% OF PRENATAL USERS WERE AT RISK OF EXCESS FOLATE OR IRON IF THEY WERE TAKING THE SUPPLEMENTS THEY TENDED TO BE OVER THE UPPER SAFE LEVELS FOR FOLIC ACID AND ALSO FOR IRON. WE'RE IN A QUANDARY HERE. THE PRENATAL NON-USERS THEIR INTAKES ARE TOO LOW AND THE PRENATAL USERS' INTAKES ARE OFTEN EXCESSIVE. WE NEED TO THINK WITH THE LEVELS OF IN THESE SUPPLEMENTS FOR THE TWO NUTRIENTS. WE ALSO NEED TO CONSIDER JUST FROM LOOKING AT THE DATABASE THE STABILITY AND BIO AVAILABILITY OF THE FOLATE SALTS. WE NEED TO THINK ABOUT WAYS OF DEVELOPING STANDARDS FOR REPORTING OF DHA AND CHOLINE PARTICULARLY BECAUSE THESE ARE INCREASINGLY PRESENT IN THE SUPPLEMENTS AND CLARIFYING RECOMMENDATION FOR TARGET GROUPS FOR PRESCRIPTION AS WELL AS OVER THE COUNTER PRENATALS AND ALSO FOR CATEGORIES SUCH AS PEOPLE UNDERGOING FERTILITY TREATMENTS. LET ME SHOW YOU A LITTLE BIT ABOUT THE USES IN CHILD NUTRITION. AND IN EVALUATING VITAMIN MINERAL SUPPLEMENT FOR CHILDREN AND HOW WELL THEY FILL THE INTAKE GAPS. LET ME SHOW YOU THAT. HERE'S A STUDY WE DID A COUPLE YEARS AGO. WE LOOKED AT ALL THE PRENATALS OR SORRY, ALL THE CHILD MULTI VITAM VITAMIN MINERALS AND THE BAR ON THE LEFT YOU SEE HOW MANY DIFFERENT PRENATALS ON THE CHILD NUTRITION SUPPLEMENTS MARKET AND WHAT THEY CONTAINED IN TERMS OF VITAMINS AND MINERALS. WE LOOKED AT THE DIETARY GUIDE LIPS AND CONSUMED AND UNDER CONSUMED IN ORANGE, THOSE WERE NOT NECESSARILY THE MOST COMMON MICRONUTRIENTS IN THE SUPPLEMENTS. ACTUALLY, SOME CONTAINED MICRONUTRIENTS WHERE THERE WAS CONCERN BY OTHER GROUPS ABOUT EXCESS. THINGS LIKE ZINC. MANY CONTAINED THE GREENS WHICH WERE NUTRIENTS THAT WE KNOW ARE PRETTY MUCH ALMOST ALWAYS ADEQUATE IN FOOD THAT CHILDREN EAT. IT GAVE US THOUGHT IN TERMS OF WHAT NEEDS TO BE DONE IN TERMS OF CHILD DIETARY SUPPLEMENTS. THE MILITARY, DR. DEUSTER GAVE A PRESENTATION ABOUT HOW THEY'VE BEEN DOING SO MUCH WORK IN TERMS OF EVALUATING PRODUCTS ESPECIALLY FOR PROBLEM INGREDIENTS AND POLICY DEVELOPMENT AND JUST LET ME MENTION ONE, HERE'S ONE THAT I DON'T THINK WE WANT ANYBODY WHO HAS ACCESS TO A GUN TO BE TAKING. AND THE SUPPLEMENT DATABASE CAN HELP IDENTIFY SOME OF THESE PRODUCTS WITH INGREDIENTS OF CONCERN. AS ALREADY MENTIONED, THE TOTAL POPULATION EXPOSURES HAVE TO INCLUDE DIETARY SUPPLEMENTS. ESPECIALLY IN PREGNANCY FOR EXAMPLE. AND WE HAD A GOOD TIME WORKING WITH PRENATALS. WHEN IT CAME TO GETTING TOTAL POPULATION ESTIMATES FOR CAFFEINE WE RAN INTO PROBLEMS. IT WASN'T ESTIMATE TOTAL POPULATION EXPOSURE TO CAFFEINE WHICH WERE OF INTEREST BECAUSE ENERGY DRINKS. REMEMBER FIVE OR SIX YEARS AGO THERE WAS A GREAT DEAL OF CONCERN ABOUT ENERGY DRINKS AND WE WANTED TO GET TOTAL ESTIMATES OF POPULATION EXPOSURES ONE PROBLEM IS THE DATABASE ALL OF WHICH HAD SOME CAFFEINE IN THEM BUT THE LABELS WERE OFTEN UNCLEAR AND INCOMPLETE DUE TO PROPRIETARY BLENDS THAT CONTAIN ONE OR MORE OF THE INGREDIENTS YOU SEE ON THE RIGHT. SO THE EXPOSURE ESTIMATES WERE FLAWED. AS A RESULT OF THAT WE COULDN'T HELP AS MUCH AS WE WANTED TO BUT STAY TUNED BECAUSE I THINK WE HAVE SOLUTIONS COMING UP THERE. I TALKED ABOUT PUBLIC HEALTH USES WITHIN GOVERNMENT BUT RESEARCHERS ARE USING THE DIETARY SUPPLEMENT DATABASE IN OTHER PLACES AS WELL AROUND THE COUNTRY. WE'RE TRYING TO OVERCOME THE CHALLENGES WE'VE RUN INTO IN TERMS OF DATA AND TECHNOLOGY AND I THINK WE'RE MAKING SOME PROGRESS. THANKS TO THE NEW SUPPLEMENT LABEL IT'S VERY CLEAR HOW YOU GET TO EXPRESS VITAMINS, MINERALS AND OTHER NUTRIENTS IN A VERY CLEAR WAY. THE PROBLEM COMES WITH THE ONES IN GREEN HERE THAT ARE ALSO INGREDIENTS AND SUPPLEMENT ARE OFTEN NOT EXPRESSED IN THE COMMON WAY ON THE LABEL AND THERE'S NO REGULATION THAT SAYS THEY HAVE TO BE. TO TRY TO MAKE A DATABASE OF THE OTHER BIO ACTIVES IS VERY DIFFICULT. YOU HAVE TO HAVE PRECISE INGREDIENT DESCRIPTIONS AND IF WE DON'T HAVE THEM, IT'S JUST IMPOSSIBLE TO MAKE A DATABASE. THE OTHER ISSUE IS THE SOFTWARE AND DATABASES AND WE'RE MAKING PROGRESS BETWEEN THE FDA AND OTHER SISTER AGENCIES AT NIH AS WELL AS OUR COLLEAGUES IN AGRICULTURE. SO THE DRUG SUPPLEMENT DATABASES ARE BEGINNING TO TALK TO EACH OTHER MUCH BETTER. BUT THOSE NON-BIO ACTIVES WILL CONTINUE TO HAVE A PROBLEM UNLESS THEY ALL SPEAK THE SAME LANGUAGE. THE TOWER OF BABEL WILL CONTINUE UNTIL THAT HAPPENS. I JUST WANTED TO THANK OUR FOUR CABINET LEVEL DEPARTMENTS THAT HAVE BEEN SO HELPFUL OVER THE PAST 10, 15 YEARS IN WORK ON THIS DATABASE AND WHAT WILL BE INTERESTING AND NOW I'M GOING TO TURN TO JAMES AFTER THANKING MY CO-COLLABORATORS ON THIS AND ASK JAMES TO PUT UP A DEMO OF OUR NEW SITE AND HOPE THAT YOU ALL TAKE THE OPPORTUNITY TO TAKE A LOOK AT IT YOURSELF AND USE IT. >> HI THERE. WELCOME TO THE DIETARY SUPPLEMENT LABEL DATABASE FROM THE NATIONAL INSTITUTES OF HEALTH. IT'S A DATABASE THAT INCLUDES CURRENT AND HISTORICAL LABEL FROM DIETARY SUPPLEMENT PRODUCTS MARKETED IN THE U.S. THE DSLD WAS LAUNCHED WITH 14,000 LABELS AND SINCE THEN IT'S GROWN TO HOUSE OVER 125,000 SUPPLEMENT LABELS IN 2021 AND COUNTING. THE OFFICE OF DIETARY SUPPLEMENTS OR ODS RECENTLY COMPLETED A REDESIGN AND MODERNIZATION OF THE DSLD TO IMPROVE THE USER EXPERIENCE OF SEARCHING THE DATABASE. SEARCHING THE DATABASE IS NOW FASTER. RESULTS ARE RETURNED MORE QUICKLY. THE DATABASE HAS ALSO BEEN RESIGNED TO SUPPORT OUR USERS IN DERIVING THE MOST VALUE FROM THE DSLD. THE WHOLE SITE BUT PARTICULARLY THE STREET INTERFACE HAS BEEN STREAM LINED TO SUPPORT USER TO FIND THE LABELS THEY NEED. USE THE GENERAL SEARCH BAR TO SEARCH FOR ANY INFORMATION THAT APPEARS ON A DIETARY SUPPLEMENT LABEL. CAN SEARCH FOR A PRODUCT OR BRAND NAME AND INGREDIENT NAME AND DIETARY CLAIM OR MORE. THE GENERAL SEARCH CASTS THE WIDEST NET AND FINDS ALL LABEL WITH YOUR SEARCH TERM REGARDLESS OF WHERE THE TERM APPEARS ON THE LABEL. OR USE THE FILTER PANEL ON THE LEFT TO REFINE YOUR SEARCH PARAMETERS OR SEARCH ON SPECIFIC PARTS OF THE LABEL. USING THE FILTERS ALLOWS YOU TO DYNAMICALLY EXPLORE THE LABELS IN THE DSLD AND FIND THE LABELS YOU'RE INTERESTED IN. AN EVER PRESENT GLOSSARY HAS BEEN ADDED TO HELP USERS LOOK UP TERMS WHILE SEARCHING THE DATABASE. ONCE YOU FOUND THE LABELS YOU'RE INTERESTED IN, YOU'RE SEARCH RESULTS CAN BE DOWNLOADED IN THREE FORMATS. CSV, EXCEL AND JASON. IF USERS ARE INTERESTED TO MIX PRODUCTS, BRANDS OR INGREDIENTS WITHIN THE DSLD THERE'S THE OPTION TO BROWSE. USERS CAN BROWSE THE DATABASE BY KEY WORD OR BY LETTER. THE SITE INCLUDES TWO NEW FEATUR FEATURES. RESOURCES FROM FEDERAL AGENCIES AND OTHER SOURCES. USERS CAN FIND MORE INFORMATION ABOUT DIETARY SUPPLEMENTS BY USING THE RESOURCES LINK FROM THE RESOURCE DIRECTORY. WE'VE ALSO ENHANCED USERS' ABILITY TO ENHANCE AND USE THE API. WE HAVE AN API GUIDE WITH ALL THE INFORMATION NEEDED TO USE DSDL DATA. FOR MORE INFORMATION CHECK OUT THE API GUIDE. WE HOPE YOU ENJOYED THE FASTER SEARCH FUNCTIONALITY AND STREAM LINED INTERFACE AND NEW FEATURES. WE'LL CONTINUE TO ROLL OUT ENHANCEMENTED OVER TIME. WE WELCOME AND ENCOURAGE YOU TO REACH OUT TO US WITH ANY QUESTIONS OR COMMENTS YOU MAY HAVE. YOU CAN CLICK CONTACT AT THE TOP OF ANY DSLD WEB PAGE TO E-MAIL US DIRECTLY. >> THANK YOU FOR THE PRESENTATION. I ESPECIALLY LIKE THE HIGH TECH. THE NEXT SPEAKER IS TALKING ABOUT YET ANOTHER -- DATABASE DIETARY SUPPLEMENT DATABASE HOUSED AS THE USDA AND KAREN ANDREWS, WOULD YOU BE KIND ENOUGH TO JOIN OUR PANEL AND GIVE YOUR TALK? THANK YOU VERY MUCH. >> THANK YOU, JOE. CAN EVERYBODY HEAR ME OKAY? >> SOUNDS GREAT. >> THANK YOU VERY MUCH AND HAPPY ANNIVERSARY TO THE OFFICE OF DIETARY SUPPLEMENTS. I'M HONORED TO PARTICIPATE IN THIS ACCOMPLISHMENT OF THE OFFICE. I'M HERE TO TALK ABOUT THE DIETARY SUPPLEMENT DATABASE AN ANALYTICALLY BASED DATABASE AND THE GOAL IS TO PROVIDE INGREDIENT ESTIMATES AND INFORMATION ABOUT VARIABILITY BASED ON CHEMICAL ANALYSIS OF CATEGORIES OF DIETARY SUPPLEMENT. WE ALSO ADDED A SECONDARY GOAL TO LOOK AT THE PERFORMANCE QUALITY. WE NEEDED INGREDIENTS DATABASE BECAUSE MANY DIETARIY RIRY RIRY -- DIETARY DATABASE AND CAN INCLUDE INTAKE CALCULATIONS IN IN DEMEO LOGICAL SURVEY TO USE MEAN ESTIMATES FROM DIETARY SUPPLEMENTS. SO IN THE 17 YEARS OF THIS PROJECT ONE OF THE NOTEWORTHY ASPECT BEEN THE COMMITMENT OF COLLABORATION AT THE ODS WITHIN THE OFFICE AND NIH AND ACROSS GOVERNMENT AGENCIES. IT'S A FOCUS I'VE BEEN INVOLVED IN AND COLLABORATION AND GREAT WILL AND HOPE THIS COLLABORATIVE APPROACH CONTINUES AT ODS AND BECOMES MORE COMMON IN OTHER SCIENTIFIC ENDEAVORS AS WELL. THE CLAN RATION ARE THE FEDERAL WORK -- COLLABORATION ARE THE FEDERAL WORKING GROUP THAT MEETS AND WE'VE HAD COLLABORATIONS WITH THE REFERENCE MATERIALS PROGRAM. WE PARTNERED WITH NIH THROUGH THEM TO GET STANDARD REFERENCE MATERIALS AND THEY'VE BEEN ESSENTIAL TO KEEPING US INFORMED AND MONITORING THE QUALITY OF THE TESTING RESULTS WE PUBLISHED. AND DEVELOPING THESE FOR SUPPLEMENTS AND CRANBERRY AND SUPPLEMENT TSTUDY I'LL BE TALKING ABOUT LATER ON. AND LOOKING AT LABEL CONTENT FOR MOST INGREDIENT WE FOUND INGREDIENT SPECIFIC RELATIONSHIPS BETWEEN THE LABEL AND THE ANALYTICAL CONTENT AND THEN IT VARIES BY DIETARY SUPPLEMENT CATEGORY AND WE FOUND THAT THE MAJOR SOURCE OF VARIABILITY IS THE DIFFERENCE IN SUPPLEMENTS THEMSELVES. THAT THE VARIABILITY WITHIN LOTS OF THE SAME SUPPLEMENT IS A MUCH MORE MINOR COMPONENT FOR MOST INGREDIENTS. SO FOR EACH OF OUR STUDIES, NATIONALLY REPRESENTATIVES ARE TESTED IN MULTIPLE LOTS AND AFTER TESTING THEM THEY'RE COMPARED TO THE LABEL AND APPLY A MIXED MODEL MEAN REGRESSION TO PREDICT THE CONTENT ACROSS A WIDE RANGE OF PRODUCT. THIS TABLE SHOWS US THE INGREDIENTS IN ADULT MULTI-VITAMINS WHERE WE PREDICT USING REGRESSION EQUATIONS WE'D SEE MORE THAN 20% ABOVE THE LABEL OF ANALYTICAL CONTENT AND THE MOST COMMON LABEL FOR THESE SUPPLEMENTS PURCHASED IN 2012 AND 2013 AND THE PERCENT OF THE RECOMMENDED DIETARY ALLOWANCE FOR THAT COMMON LABEL AND YOU CAN SEE THAT MOST THE PRODUCTS WERE AT 100% OR MORE OF THE RDA. VITAMIN D IS LESS THAN THE RDA AND I'LL SHOW YOU SOME DETAILS. OF THE 106 PRODUCTS IN THE STUDY, 93 HAD VITAMIN D. THE GRAPH SHOWS INDIVIDUAL PRODUCT RESULTS. BLUE BARS ARE THE LABELS AND THE RED BARS ARE THE ANALYTICAL CONTENT. WE SEE A RANGE OF PERCENT DIFFERENCES FROM MINUS 60% OF LABEL TO PLUS 80% OF LABEL. WE HAD ONE PRODUCT. THIS ONE HERE CAME IN AT SIX TIMES THE LABEL LEVEL. MOST PRODUCTS ARE LABELLED BELOW THE RDA BUT IF YOU ADD THE OVERAGES IF YOU REMEMBER FROM THE LAST SLIDE IT WAS PACKAGED 40% ABOVE LABEL. IF WE ADD THE AVERAGES IN, MOST THE PRODUCTS ARE ACTUALLY PROVIDING VITAMIN D CONTENT ABOVE THE RDA AND SOME ABOVE THE TOLERABLE UPPER LIMIT AT THE TIME. SO NOR INFORMATION ABOUT OTHER INGREDIENTS IN ADULT MULTI-VITAMINS AND OTHER CATEGORIES, PLEASE SEE OUR WEBSITE. WE ACTUALLY HAVE ON OUR WEBSITE FROM THE DATA FILE SECTION WE HAVE TABLES WITH OUR REGRESSION RESULTS BY DIETARY SUPPLEMENT CATEGORY AND INGREDIENT LEVEL AND WE LEAVE THESE DATA TO DIETARY SUPPLEMENTS REPORTED IN NHANES TO FACILITATE MORE NHANES ASSESSMENT. LOOKED AT BOTANICAL AND CURCUMIN AND TURMERIC AND WITH BOTANICALS THE FDA REQUIRES ONLY THE BOTANICAL MATERIAL IN THE PRODUCT. IT COULD BE A DRIED LEAF POWDER OR COULD BE A HIGHLY CONCENTRATED EXTRACT. BASED ON THAT, THESE ARE OUR MAJOR QUESTIONS FOR THE PANEL. HOW WELL DOES THE RATE OF THE BOTANICAL MATERIAL PREDICT ACTIONABLE CONTENT OF BIO ACTIVES AND SINCE LABELLING OF THE CONCENTRATION LABEL NOT REQUIRED DO THE VOLUNTARY CLAIMS PROVIDE ACCURATE INFORMATION. IN OUR STUDIES WE FOUND A WIDE RANGE OF CONSTITUENTS WITH THE SAME LABEL CLAIM AND THE VOLUNTARY CONCENTRATION CLAIM CONTAIN SIGNIFICANTLY HIGHER LEVELS THAN THOSE WOULD THE CLAIM AND POSITIVE CORRELATIONS BETWEEN VOLUNTEERING CONTENT AND ACTUAL CONTENT. I'LL SHOW YOU A FEW QUICK EXAMPLES. THIS SAY GRAPH SHOWING RESULTS FOR SUPPLEMENTS WITH GREEN TREE AS THE PRIMARY INGREDIENT AND ONLY BOTANICAL. OTHER SUPPLEMENTS WERE TESTED FOR THEIR CONTENT AND EGCG AND THE REGRESSION ANALYSIS SHOWS THAT THE RELATIONSHIP THOUGH WE SAW SOME RELATIONSHIP WITH THE HIGHER AMOUNT AND THE AMOUNT OF EGCG IN THE PRODUCTS. WHEN WE LOOK AT 18 OF THE PRODUCTS THAT HAD A VOLUNTARY CLAIM FOR EGCG WE SEE A POSITIVE CORRELATION BETWEEN THE LABELLED AND ANALYTICAL AMOUNT. IT'S A BETTER INDICATOR FOR CONSUMERS THAN THE RETIRED AMOUNT. -- REQUIRED AMOUNT. AND THE OTHER IS HOW WELL DO DIETARY SUPPLEMENTS IN PILL FORM BREAK APART AND IT'S REQUIRED FOR ALL DRUGS BUT NOT REQUIRED FOR MOST DIETARY SUPPLEMENTS. THE INTEGRATION AND DISINTEGRATION IS IMMERSED AND AGITATED FOR HALF AN HOUR AND THEN EVALUATES TO SEE IF IT WAS COMPLETELY BROKEN A PART AND PASSES. IN THE SOLUTION, THAT TABLETS AN CAPSULES WERE INTEGRATE AND THE MARKER COMPOUND IS COMPARED TO THE LABEL CLAIM AND IF IT'S GREATER THAN 75% IT PASSES DIS DISSOLUTION AND USP FOR THE MULTI-VITAMIN PRODUCT IS NOT REQUIRING DISINTEGRATION BUT REQUIRED DISSOLUTION IF YOU LOOK AT THEIR PRODUCTS. GELS UNDER GO RUPTURE TEST AND IF THEY OPEN UP AT ALL THEY'RE CONSIDERED PASSING. AND LESS LIKELY TO PASS ARE CAPSULES AND LEAST LIKELY ARE TABLETS BECAUSE THEY'RE MANUFACTURED WITH COMPRESSION AND IT'S FAIRLY EASY TO OVERCOMPRESS A TABLET. TO SO THE NON-PRENATAL ONES HAVE 90% RATE AND IN THE SMALLER PRENATAL MULTI-VITAMIN STUDY WE ALWAYS HAD TABLETS AND SOFT GELS AND SEE THE DIFFERENCE IN DISINTEGRATION RATES AND FOR ALL THREE BOTANICAL STUDIES THEY'RE ALMOST ALL CAPSULES AND WE SEE TURMERIC AND CRANBERRY AND GREEN TEA HAS A LOWER PASS RATE. THIS IS MORE OF A LOT RATIO WE THEORIZE THE ECGG MAY HAVE HARDEN THE SHELL TO IMPEDE DISINTEGRATION. AND ONLY 20% OF PRODUCTS TESTED PAS PASSED AND THE PASS RATE WAS HIGHER FOR GELATIN CAPSULES AND MY COLLEAGUE PUBLISHED AN ARTICLE ABOUT ALL THESE RESULTS. IF YOU'RE INTERESTED AND I DID PULL OUT THIS ONE CONCLUSION THAT WE PUBLISHED IN THE PAPER THAT WIDESPREAD INADEQUATE DIETARY PERFORMANCE MAY HELP EXPLAIN VARIABLE RESULTS ABOUT THE RISKS AND BENEFITS OF GREEN TEA DIETARY SUPPLEMENTS AND WE RECOMMEND SATISFACTORY DOSAGE FORMS BE REQUIRED DUE TO VARIABILITY IN PERFORMANCE. WE ALSO TESTED OUR PRESCRIPTION PRENATAL VITAMINS FOR DISSOLUTION AND IT REQUIRES THREE OR FOUR VITAMINS TO BE TESTED FOR THE ENTIRE PRODUCT TO PASS DISSOLE -- DISSOLUTION AND OF THE TABLETS LOOKED AND THE ORANGE BAR IS THE PERCENT IS THE ANALYTICAL AMOUNT AND 12 OF THE PRODUCTS PASSED IN ONE OR TWO LOTS. TWO PRODUCTS HERE IN THE MIDDLE BOTH FAILED, BOTH LOTS FAILED TO PASS DISSOLUTION TESTING AND ONE PRODUCT FAILED IN ONE LOT AND PASSED IN THE OTHER. SO THEY COME ON THE REST OF THE INGREDIENTS AND PRESCRIPTION PRENAT PRENATALS. IN CONCLUSION MANY DIETARY SUPPLEMENTS CONTAIN HIGH AMOUNTS OF NUTRIENTS AND IT SHOULD BE ACCOUNTED FOR IN INTAKE CALCULATIONS FOR EPIDEMIOLOGIC SERVICES AND DIETARY SUPPLEMENTS MAY NOT RELEASE THEIR NUTRIENTS AND BIO ACTIVES IN DOSAGE FORMS. PERFORMANCE QUALITY IS NOT REQUIRED TO BE STANDARDIZED AND MONITORED FOR LOWEST DIETARY SUPPLEMENTS. SO CURRENTLY WE HAVE TWO STUDIES ONGOING. A NATIONAL STUDY OF CALCIUM SUPPLEMENTS TESTING ADULTS AND CHILDREN FOR MINERALS, VITAMIN D, DISINTEGRATION AND DISSOLUTION. WE'RE JUST BEGINNING A TEST LOOKING AT 50 CRANBERRY PRODUCTS THAT ARE PROBLEM -- POPULARLY SOLD AND TESTING THEM FOR CONTENT AND USING THE INDUSTRY STANDARD AND NEW METHODS EVALUATING THE TYPE A PACK CONTENT. THAT IS IMPORTANT BECAUSE MANY PEOPLE BELIEVE IT IS THE ACTIVE INGREDIENT THAT IS RESPONSE IBLE AND WE'RE GOING TO TAKE THEM FOR DISSOLUTION AND DISINTEGRATION AND LOOK AT FOLATE IN DIETARY SUPPLEMENT AND TESTING FOR LABEL INTEGRITY AND CONTENT AND ANSWER QUESTIONS ABOUT STABILITY. I'D LIKE TO TAKE THIS OPPORTUNITY TO THANK THE TEAM FOR THEIR HARD WORK AND DEDICATION TO THANK ALL OF OUR COLLABORATORS ESPECIALLY THE OFFICE OF DIETARY SUPPLEMENTS AND I WANTED TO ESPECIALLY ACKNOWLEDGE THE LEADERSHIP OF DR. JOHANNA DWYER WHO HAS BEEN THE PRINCIPLE INVESTIGATOR FOR THIS PROJECT. SHE'S A PLEASURE TO WORK WITH AND OUTSTANDING SCIENTIST. THANK YOU. >> AT THIS POINT WE'LL TURN THE CHAIR OVER TO ADAM KUSZAK TO INTRODUCE THE ANALYTICAL METHODS AND REFERENCE MATERIALS PROGRAM. ADAM. >> THANK YOU, JOE. HELLO, EVERYBODY. HELLO EVERYBODY. I'M THE DIRECTOR OF THE ODS ANALYTICAL METHODS AND REFERENCE MATERIALS PROGRAM. AND A CONSISTENT THEME IS HOW CRITICAL CONSIDERATION IN DIETARY SUPPLEMENT RESEARCH IS KNOWING THE COMPOSITION OF THE EXPERIMENTAL INTERVENTION. WE'VE SEEN THE IMPORTANCE OF SPECIFYING VITAMIN ISO FORMS AND THE DOSING AND THE PARTICULARS OF THE PLANT PART USED FOR BOTANICAL SUPPLEMENT. FOR ALL THE CHEMICAL CHARACTERIZATION CAN BE FOUNDATIONAL TO RIGOROUS RESEARCH AND SELECT REVIEWS AND GUIDELINES AND RESOURCES COVERING THE TOPIC OF ANALYTICAL CHARACTERIZATION IS PROVIDED BY ODS AT THE WEBSITE YOU SEE HERE. IT WAS DEVELOPED TO IMPROVE RESEARCH THROUGH QUANTITATIVE ANALYSIS AN SUPPORTS METHOD DEVELOPMENT AND VALIDATION IN REFERENCE MATERIAL PRODUCTION AND LABORATORY ASSURANCE EXERCISES. THEY'RE DESIGNED TO WORK TOGETHER TO HELP SCIENTISTS ANSWER QUESTIONS ABOUT THE IDENTITY AND COMPOSITION OF DIETARY INGREDIENTS IN SUPPLEMENT PRODUCTS, BOTANICAL AND BIOLOGICAL SAMPLES. OVER THE PAST NEARLY 20 YEARS, AMRM AND ITS PARTNERS MADE REFERENCE MATERIALS AVAILABLE FOR STUDY AND REFERENCE. THEY'RE IMPORTANT FOR STUDY AND TO LOOK AT METHODS AND REPRODUCIBILITY. THIS AREA OF THE PROGRAM ENGAGED WITH INDUSTRY AND REGULATORY STAKEHOLDERS TO DEVELOP CONSENSUS STANDARDS AND ESTABLISH OFFICIAL METHODS OF ANALYSIS FOR DIETARY SUPPLEMENT AND MEASURE NUTRIENT OR PHYTO CHEMICALS IN AGENTS OR SPECIMENS. IT'S HELPED INVESTIGATORS PUBLIC THEIR STATE OF THE ART METHODS TO IMPROVE METHODS OF THE DIETARY INGREDIENTS AND THEIR METABOLITES HYPOTHESIZED TO PROMOTE HEALTH BY MITIGATING ANG ANXIETY OR DEPRESSION AND MITIGATING CANCER OR DEPRESSION. TURMERIC IS ONE OF THOSE DIETARY INGREDIENTS WHERE QUESTIONS ABOUND FOR THE BIO AVAILABILITY AND PURPORTED MECHANISMS OF ACTION FOR ITS CONSTITUENTS AND BRINGS ME TO THE PLEASURE OF INTRODUCING DR. SCHNEIDER AND HIS INTERESTS ARE IN THE FORMATION OF BIO ACTIVE LIPID MEDIATORS AND UNDERSTANDING OF MECHANISMS OF ACTION FOR BIOACTIVE DIETARY COMPOUNDS AND HAS A SPECIAL FOCUS ON THE COMPOUND CURCUMIN FROM TURMERIC. THE FLOOR IS YOURS AND WELCOME. >> I'D LIKE TO THANK THE AUDIENCE FOR INVITING ME TO THE SYMPOSIUM AND PRESENT OUR WORK ON CURCUMIN. AND WITH THAT SOME ARE FAMILIAR WITH THE CURCUMIN AND THE CONTROVERSIES AROUND THE COMPOUND. THE CONTROVERSY ACTUALLY BEING THE QUESTION OF WHETHER CURCUMIN HAS SHOWN ANY BIOLOGICAL ACTIVITY IN HUMANS. AND CURCUMIN ALSO HAS RECEIVED A LOT OF BAD PRESS IN PRESENT YEARS AND WITH SOME PEOPLE QUESTIONING WHETHER BECAUSE WORK WITH CURCUMIN IS DIFFICULT AND COMPLICATED WHETHER IT'S WORTHWHILE DOING RESEARCH ON CURCUMIN. SO WITH THAT IN MIND THERE'S A REALITY ABOUT CURCUMIN AND WE'RE LOOKING AT THE GLOBAL OUTLOOK 2018 TO 2025. THE CURCUMIN MARKET IS EXPECTED TO REACH $100 MILLION BY 2025 AND THIS IS FIGURING IN AN ANNUAL GROWTH RATE OF ABOUT 9% FOR THE MARKET. AND THE REASON FOR THAT IS THAT THE MARKET ACTUALLY SAYS AND I'LL READ HERE FROM THIS MARKET OVERVIEW, CURCUMIN EXHIBITS ANTI-IN INFLAMMATORY AND ANTI-OXIDANT PROPERTIES MAKING IT IDEAL IN MEDICAL AND FOOD MARKET AND IT'S EXPECTED TO LOOK AT GROWTH IN CONSUMER AWARENESS REGARDING ITS THERAPEUTIC PROPERTIES AND SAY UP HERE, CURCUMIN IS THE BIO ACTIVE COMPOUND IN TURMERIC. SO THE FUTURE OF CURCUMIN IS GOLDEN, IF I MAY SAY SO TO DO A BAD JOKE ON THIS COLOR OF CURCUMIN AND CAN SEE PROJECTED SALES IN THE U.S. MARKET. THIS MARKET OUTLOOK AT CURCUMIN IS COMPLETELY DIFFERENT AND UNAFFECTED BY ANY SCIENTIFIC CONTROVERSIES ABOUT CURCUMIN BUT WHO ARE THESE PEOPLE CONSUMING CURCUMIN. HERE SAY STUDY BY MY COLLEAGUE AND COLLABORATOR FROM THE UNIVERSITY OF ARIZONA AND SHE WAS LOOKING AT NON-VITAMIN, NON MINERAL DIETARY SUPPLEMENT USE IN INDIVIDUALS WITH RHEUMATOID ARTHRITIS. WE'RE LOOKING AT CURRENT USE AND SEE AT TOP OF THE LIST IS THE TURMERIC IE CURCUMIN WITH USE IN THE PATIENTS AS SIMILAR AS WE HAVE WITH OMEGA 3 FAT Y ACIDS. WE'RE INTERESTED IN THE MOLECULE OF CURCUMIN AND HOW CAN IT AFFECT ITS TARGETS AND HAVE BIOLOGICAL ACTIVITY AND WHAT ARE THE STRUCTURAL ELEMENTS AND THE CHEMICAL ELEMENTS RELEVANT ABOUT CURCUMIN AND THE QUESTION WHETHER THE METABOLISM COULD PLAY A ROLE IN MEDIATING BIOLOGICAL AFFECT. SO AGAIN, WE'RE LOOKING AT THE STRUCTURE OF CURCUMIN AND YOU CAN SEE THE DOUBLE BONDS ARE ALL DELOCALIZED AND CONJUGATED OVER THE ENTIRE MOLECULE. THAT RESULTS IN THE ORANGE TO YELLOW COLOR OF CURCUMIN AND CAN SEE THE ORANGE COLOR IN THE UV SPECTRUM OF CURCUMIN WHICH SHOWS A NICE AMOUNT OF NANO METERS BUT IF YOU COME BACK AFTER A MINUTE AND SCAN THE SOLUTION AGAIN AND ANOTHER MINUTE AND ANOTHER MINUTE AND ANOTHER MINUTE, WE CAN SEE THE ABSORBENS OF CURCUMIN GOES AWAY SO IT'S DEGRADED WHILE WE LOOK AT IT. WITHIN 10 MINUTES ALL THE CURCUMIN HAVE YOU IN THE SOLUTION IS GONE. AND THEY SEE THE ACTIVE COMPOUND DISAPPEARS AND THERE GOES THE GOOD STUFF. AND WE LOOK AT WHAT NEW COMPOUNDS ARE FORMED AND ARE THEY POSSIBLY BIO ACTIVE. WHEN WE WERE STUDYING OUR INVESTIGATIONS AND CURCUMIN IT WAS KNOWN IT CAN UNDER GO REDUCTION NEVER TO FORM METABOLITES LIKE HEX IDE AND GET RID OF THE DOUBLE BONDS OR COULD HAVE PHASE 2 METABOLITES BY CONJUGATION WITH THE ACID OR SULPHATE AND THESE CAN BE LOOKED AT AP . AND THE INSTABILITY OF CURCUMIN HAS BEEN WELL KNOWN. WE WEREN'T THE FIRST TO DESCRIBE THEM AS UNSTABLE BUT THE FIRST TO FIGURE OUT WHAT IS HAPPENING DURING THE DEGRADATION OF CURCUMIN. THERE'S A PAPER FROM ABOUT 20 YEARS AGO, MAYBE 30 YEARS AGO BY NOW THAT SAYS CURCUMIN DESCRIBES THE DEGRADATION AND DESCRIBE THE ACID OF MINOR PRODUCTS BUT HAS ALWAYS BEEN MISUNDERSTOOD AS THESE ARE THE MAIN OR ONLY DEGRADATION PRODUCTS OF CURCUMIN. I'LL TELL YOU A LITTLE BIT ABOUT MORE ABOUT OUR STUDIES TO FIGURE OUT WHAT IS HAPPENING DURING THE DEGRADATION OF CURCUMIN. LET ME START BY SHOWING THE STRUCTURE AND WE LOOK AT THIS. AND YOU CAN SEE IT LOOKS NOTHING LIKE CURCUMIN. LET ME BRIEFLY WALK YOU THROUGH THE MOLECULE HERE. WE HAVE THESE RINGS SAME AS CURCUMIN AND WHAT CONNECTS THE RINGS AND THEY'RE STILL IN PLACE BUT JUST LOOK DIFFERENT NOW. NOW WE'RE GOING ONE, TWO, THREE, FOUR, FIVE, SIX, SEVEN LIKE HERE AND HAVE A NEW CARBON BOND BETWEEN TWO AND SIX. WE STILL HAVE THE STABLE ONE HERE AS WELL AND WE HAVE A NEW OXYGEN COMING IN BETWEEN ONE AND SEVEN AND THAT'S BETWEEN HERE AND HERE AND HAVE A NEW CARBON WALL AND ONE OF THE RINGS AND THEY'RE DIFFERENT IN COLORS. A LOT OF HAS HAPPENED DURING THE DEGRADATION OF CURCUMIN. WHEN WE WANTED TO FIGURE OUT WA WAS HAPPENING TO CURCUMIN, WE PLACED THIS AND LET IT GO OFF WITH UNLABELLED CURCUMIN AND WE CAN SEE A LOT OF DIFFERENT PRODUCTS FORMED DURING THE DEGRADATION OF CURCUMIN AND I'M LABELLING THEM HERE AND WE ISOLATED ALL OF THEM AND FIGURED OUT THEIR STRUCTURES AND THEY'RE SHOWN HERE. DOWN HERE IS THIS FINAL PRODUCT THAT WE SEE AND THE RING AND WE CAN SEE IT'S ACTUALLY PRESENT IN MOST OF THESE PRODUCTS. AND KNOWING WHAT PRODUCTS ARE FORMED AND WHAT PRODUCT MEDE AND USING OXYGEN LABELLING STUDY HELP US TO FIGURE OUT THE MECHANISM HOW WE GET FROM HERE, CURCUMIN TO THIS DURING THE CHEMICAL DEGRADATION. THIS IS SHOWN HERE. LET ME WALK YOU THROUGH THIS BRIEFLY. THE INITIAL REACTION IS AN ABSTRACTION AT THE HYDROXAL AND IT SIT AT CARBON 2 AND REACTS WITH THE DOUBLE BOND TO FORM THIS GROUP HERE AN IT PICK UP MOLECULAR OXYGEN TO FORM THIS RADICAL WHICH IS THEN ADDS TO THE DOUBLE BOND OF THIS SITE HERE AND END UP WITH THE SUBSTITUTION HERE OF THE RADICAL AND IT THEN WOULD CATALYZE THE ABSTRACTION HERE. THEN WE END UP WITH THIS COMPOUND HERE AND IT'S THE FIRST COMPLETE COMPOUND IN THE REACTION MECHANISM AND THE FIRST INTERMEDIATE WE COULD ISOLATE FROM THE DEGRADATION OF OCCUR TOMBIN. AND WE HAVE THE HIDROXAL. AS WE WERE LOOKING AT THE STRUCTURES WE WERE DRAWING HERE TO UNDERSTAND THE MECHANISM OF DEGRADATION, WE REALIZE WE'RE LOOKING AT REACTIVE MOLECULES. THIS IS RATHER ELECTROPHILIC. THEY HAVE AN ENDOPEROXIDE AND THIS IS ALSO REACTIVE. THIS THEN FOSTERED THE HYPOTHESIS THAT THE THOUGHT MAYBE THIS DEGRADATION IS ACTUALLY A METABOLIC ACTIVATION AND CURCUMIN AT LEAST IN PART FOR PART OF ITS BIOLOGICAL AFFECT IS A PRO DRUG THAT UNDER GOES THIS METABOLIC ACTIVATION AND THEN SOME DEGRADATION PRODUCTS LOOK AT EFFECTS OF CURCUMIN. THE WAY WE WENT ON TO STUDY IT IS THAT WE MADE A BUNCH OF ANALOGS OF CURCUMIN SYNTHETICALLY AND WE START FROM THIS AND YOU CAN READILY MODIFY THE VANILLAN AND WE COMPARED THE STABILITY OF THESE ANALOGS AND THE BIOLOGICAL ACTIVITY. AS A BIOLOGICAL ACTIVITY, WE WERE ACTUALLY LOOKING AT THE INHIBITION OF ONE OF THE MAJOR PATHWAYS OR MECHANISMS BY WHICH CURCUMIN EXERTS ANTI-INFLAMMATORY ACTIVITY AND COMBINE ONE ASSAY AND ONE MEASURE THE ACTIVITY OF CURCUMIN. THE IEC50 FOR INHIBITION OF THE CELLULAR ASSAY AND MEASURING THE ACTIVITY AND STABILITY OF CURCUMIN AND WE CALCULATE A RATE OF DEGRADATION. THIS IS THE RESULT SHOWING FOR CURCUMIN AND WE DID THAT FOR A NUMBER OF ANALOGS AND CAN SEE SOME ANALOGS ARE MORE STABLE THAN CURCUMIN. SOME ARE LESS UNSTABLE AND SOME ARE LESS ACTIVE AND SOME ANALOGS ARE MORE ACTIVE THAN CURCUMIN. SO THEN WE PLACED THESE DIFFERENT RESULTS THAT WE HAD WITH A DIFFERENT COMPOUND INTO THIS GRAPH HERE WHERE WE'RE PLOTTING ON THE Y AXIS TO IC50 SO THE LESS ACTIVE COMPOUNDS HAVE THE HIGH ACTIVE, HIGH IC50 UP HERE AND MORE ACTIVE COMPOUNDS ARE DOWN HERE SO GOING DOWN WE INCREASE BIOLOGICAL ACTIVITY AND TO THE RIGHT WE'RE INCREASING INSTABILITY. SO UP HERE IS THE COMPOUNDS THAT QUICKLY ARE DEGRADE. WE GET A NICE CORRELATION FOR THE NEW ANALOGS THAT WE'VE MADE SHOWING THAT THE MORE UNSTABLE THE COMPOUND IS THE ANALOG OF CURCUMIN THE MORE ACTIVITY BECOMES AND CONVERSE THE MORE STABLE THE COMPOUND THE LESS ACTIVE IT IS. CURCUMIN IS HERE AND LET ME POINT OUT THE CON POUND TURNED OUT TO BE THE CLOSEST IN THE FEATURES COMPARED TO CURCUMIN AND I'LL COME BACK TO TELLING YOU A LITTLE BIT ABOUT COMPOUND A TOWARDS THE END OF THE TALK. THIS IS THE UNSTABLE INTERMEDIATE WHICH IS ACTIVE AND THERE'S A RATHER DIFFICULT TO HANDLE COMPOUND AND THE STABLE FINAL PRODUCT IS INACTIVE. NO ACTIVITY WITHIN THIS. AGAIN SUPPORTING THE ASSUMPTION THAT IT'S CURCUMIN AND DEGRADATION PRODUCTS MEDIATING THE BIOLOGICAL ACTIVITY. AND HOW IS IT MEDIATED. I'M SURE YOU KNOW THE PROINFLAMMATORY TRANSCRIPTION FACTOR THAT DRIVES THE TRANSCRIPTION OF GENE INVOLVED IN CELL FORM AND UNITY AND CAN ENTER THE NUCLEUS BECAUSE IT'S USUALLY COMBINED WITH THIS. AND ONCE IT'S PHOSPHORYLATED IT'S DEGRADED AND CURCUMIN CAN GO TO THE NUCLEUS AND DO ITS TASK AND IT'S REGULATE THIS KINASE BETA AND THIS IS THE KEY TARGET OF MANY CELLULAR ELECTROPHILES. THEY COVALENTLY BIND TO THE NUCLEAR PHILLIC REACTION AND ONCE IT BINDS IT STARICLY BLOCKS THE SARIN RESIDUES 177 AND 181 THAT NEED TO BE PHOSPHORYLATED FOR THE KINASE TO BE ACTIVE AND THEY'RE GLUTAMATES. SO THE ELECTRIFIED ONE HAS THE I KAPPA B IS TURNED OFF AND WANT TO KNOW IF CURCUMIN BINDS TO THE SITE. WE HAD A COMPANY SYNTHESIZE TWO SYNTHETIC PEPTIDES THAT COVER THE IKK BETA AND TEST WHETHER THE WILD TYPE HAVING ONE HERE AND THE MUTANT ONE IS REACTIVE WITH THE METABOLITES AND DID ANALYSIS TO TELL YOU WE COULD SHOW CURCUMIN IS BINDING AND AND IT'S BINDING THE PEPTIDE. AND THIS IS NOT BINDING JUST AS WE WOULD HAVE PREDICTED. AND MEDIATES THE BINDING. WE'RE SHOWING BINDING TO A PEPTIDE AND DO THEY BIND TO PROTEIN AS WELL? WE USE THE COMPOUND A I POINTED OUT THE STRUCTURE OF WHICH IS SHOWN HERE. IT'S ACTUALLY A KIND OF CURCUMIN AND FACILITATED PROTEOMIC STUDIES AND PUT THIS IN THE COMPOUND IN ORDER TO MAKE IT BREAK DOWN AT THE SAME RATE AT CURCUMIN DOES. THE IDEA IS THEN WE MIXED THIS WITH CELLULAR PROTEIN AND IT WOULD BIND AT THESE ELECTROPHILIC SITES AND IT'S STILL AVAILABLE TO REACT SO WE CAN FLUORESCENTLY LABEL ALL THE PROTEINS THAT HAVE BEEN ADOPTED BY CURCUMIN. WE'RE LOOKING AT THE DOSE DEPENDENT TREATMENT OF THE CELLS WITH THIS COMPOUND AID RESULTS IN INCREASED FLUORESCENCE OF PROTEIN, WHATEVER PROTEIN IT IS OF THESE RAW CELLS. AND IF WE COMPARE A MORE STABLE CURCUMIN ANALOG THAT HAS A TAG WE CAN SEE AT SIMILAR CONCENTRATIONS THERE'S MUCH LESS LABELLING OF PROTEIN THAN WITH THE UNSTABLE CURCUMIN ANALOG. FURTHERMORE WE'RE LOOKING AT PREINCUBATION OF CURCUMIN AND CELLS BEFORE WE LABEL THE CELLS WITH FINAL CURCUMIN. THIS IS JUST LABELLING CELLS WITH THE NICE FLUORESCENCE OF PROTEINS IN THE CELLS WITH CURCUMIN ITSELF THERE'S BARELY FLUORESCENCE BECAUSE IT HAS THIS. IF WE PRETEAT THE CELLS IT GOES AWAY VALIDATING THAT OUR CURCUMIN IS A VALID PRO TO MIMIC PROTEIN BINDING BY CURCUMIN. IF WE USE A COMPOUND, A CURCUMIN ANALOG NOT ACTIVE AND STABLE IT CANNOT PREVENT THE LABELLING OF PROTEIN BY THIS KIND OF CURCUMIN. IF WE TREAT WITH A HIGHLY UNSTABLE COMPOUND AND ANALOG OF CURCUMIN, IT BLOCKS ALL THE BINDING OF OUR PROBE INDICATING A LOT OF THE MATH AUTHORITY PROTEIN COMBINING IS MEDIATED BY THE DEGRADATION PARTICLES. LET ME SUMMARIZE WHAT I JUST TOLD YOU. CURCUMIN IS A BIOACTIVE COMPOUND IN CELLS. IT MAINLY HAS ANTIINFLAMMATORY ACTIVITIES AND ALSO OTHER ACTIVITIES. IT'S ANTIOX ACCIDENT ACTIVITY. THE ANTIOXIDANT ACTIVITY RESULTS IN THE OXIDATION OF CURCUMIN. IT'S AN OXIDATION THAT CAN BE EN SOMATICALLY CATALYZED BY PEROXIDASE AND WE THINK IT CONTRIBUTES TO THE BIOLOGICAL ACTIVITY AND THE METABOLISM AND THEY'RE LESS ACTIVE IN THESE REACTIVE METABOLITES CAN BE CAPTURED IN WATER INTO STABLE METABOLITES THAT WOULD BE LESS ACTIVE. WE THINK ACTIVATION IS REQUIRED FOR AFFECTS BY OXIDATIVE STRESS BINDING MAY REQUIRE BOINEDING IN VIVO AND PROVIDE TISSUE AND DISEASE SPECIFIC TISSUE ACTIVATION. WITH THAT I'D LIKE TO THANK YOU FOR THE INVITATION TO PRESENT RESULTS ON THE CURCUMIN. THESE ARE THE FOLKS WORKING ON MY LAB OVER THE YEARS. WE FORESEE FUNDING FROM THE NCCIH ON OUR CURCUMIN PROJECT FOR YEARS AND RO1 FOR MY GRAD USE STUDENT AS AN R31 AND WE ALSO HAVE ODS HAVING CHIPPED IN SOME MONEY AND YOU CAN CONTACT ME IF YOU HAVE QUESTIONS ON CURCUMIN AND INTERNATIONAL AND NATIONAL COLLABORATORS WE WORKED WITH AND THANK YOU FOR YOUR ATTENTION. >> WE'LL MOVE ON TO THE EDUCATION AND COMMUNICATION SECTION BUT I'LL REMIND OUR PANELIST TO KEEP TRACK OF THE QUESTIONS AND ANSWERS IN THE QUESTION AND ANSWER BOX FOR INSTANCE, THERE WAS ONE T JUST ONE POSTED FOR CLAUS AND IF YOU'LL BE AROUND FOR THE DISCUSSION AND CLOSING REMARKS THIS AFTERNOON THAT WOULD BE GREAT OPPORTUNITY FOR TO YOU ADDRESS THAT QUESTION. AND PREFER YOU HAVE THE QUESTION AND ANSWER FUNCTION BECAUSE THE CHAT HAS A LOT OF BACK AND FORTH CHATTER WHETHER WE CAN SEE PEOPLE OR HEAR THEM IT'S CLEANER IN TERMS OF THE QUESTIONS AND AERNSZS PART THEIR DISCUSSION. THANK YOU AND OUR NEXT SPEAKER IS PAUL THOMAS AND CARE HAGGANS TO SPEAK ABOUT THE COMMUNICATION AND EDUCATION PROGRAM AT ODS. TAKE IT AWAY. >> I'M PAUL THOMAS AND WITH THE ODS COMMUNICATIONS PROGRAM FOR SOME 15 YEARS. AND TOGETHER WITH MY COLLEAGUE, CAROL HAGGANS WHILE PROVIDE AN OVERVIEW OF THE ODS COMMUNICATION AND EDUCATION RESOURCES OVER THE YEARS. WHAT ESTABLISHED OUR EDUCATION AND IN THAT LAW CONGRESS SAID THERE'S A QUOTE, GROWING NEED FOR DISSEMINATION AND INFORMATION LINKING NUTRITION AND LONG-TERM GOOD HEALTH, END QUOTE. AND IN ESTABLISHING ODS CONGRESS LAID OUT ONE OF OUR PRIME DUTIES TO QUOTE, COLLECT AND COMPILE THE RESULTS OF SCIENTIFIC RESEARCH RELATING TO DIETARY SUPPLEMENTS END QUOTE. FROM THE VERY BEGINNING, ODS DEVELOPED RESOURCES THAT PRESENT THE SCIENCE AND WHAT WE KNOW ABOUT THE EFFICACY, SAFETY AND QUALITY OF DIETARY SUPPLEMENT INGREDIENTS. THAT'S TO HELP OUR VARIED AUDIENCES MAKE THEIR OWN DECISIONS WHETHER OR NOT TO TAKE THE PRODUCT AND WHEN AND HOW MUCH AND WHAT KINDS THEY MAY TAKE. HERE'S AGE IMAGE OF THE HOME PAGE OF THE ODS WEBSITE. WE RECENTLY REDESIGNED IT TO IMPROVE NAVIGATION AND GAVE IT A FRESH LOOK AND GETS 1.5 MILLION VISITS PER MONTH AND ON THE RIGHT ARE SOME RESOURCES WE'LL BE COVERING ALL OF WHICH ARE AVAILABLE FROM OUR WEBSITE. EVERYTHING FROM OUR DIETARY SUPPLEMENT FACT SHEETS TO OUR SEMINAR SERIES AND NEWS LETTERS AND VARIES PROGRAM AND ACTIVITIES. THERE'S FACT SHEET WITH GENERAL INFORMATION ABOUT DIETARY SUPPLEMENT USE. WE HAVE MORE THAN TWO DOZEN FACT SHEET FOR SPECIFIC INGREDIENTS THAT DETAIL THE USE, SAFETY AND EFFECTIVENESS OF VITAMINS AND MINERALS AND OTHER INGREDIENTS SUCH AS PROBIOTICS AND FISH OIL. WE ALSO HAVE FACT SHEETS MARKETED FOR SPECIFIC PURPOSES LIKE FOR WEIGHT LOSS AND EXERCISE AND ATHLETIC PERFORMANCE AND A RECENT ONE ON DIETARY SUPPLEMENTS AND THE TIME OF COVID. AND THERE'S OUTSIDE EXPERTS TO ENSURE THEY'RE ACCURATE AND THOROUGH AND AVAILABLE IN THREE VERSIONS. A DETAILED VERSION WITH SCIENTIFIC REFERENCES DIRECTED TO HEALTH CARE PROFESSIONALS AS WELL AS EASIER TO READ VERSIONS FOR CONSUMERS IN BOTH ENGLISH AND SPANISH WITHOUT ALL THE DETAILS AND REFERENCES. HERE'S A BACKGROUND FACT SHEET CALLED DIETARY SUPPLEMENTS WHAT YOU NEED KNOW AND PROVIDES GUIDANCE ON DIETARY SUPPLEMENT USE LIKE THINGS TO CONSIDER BEFORE TAKE SUPPLEMENT AND SAFETY CONSIDERATIONS INCLUDING POSSIBLE SAFETY RISKS WITH HIGH DOSES AND POTENTIAL INTERACTIONS WITH MEDICATIONS. AND IT HIGHLIGHTS A COMMON THEME THROUGHOUT ALL OF OUR FACT SHEETS WHICH IS TAUT TALK WITH YOUR HEALTH CARE PROVIDER FOR ADVICE ON DIETARY SUPPLEMENTS. IT'S MADE AVAILABLE IN ENGLISH AND SPANISH. THIS GETS ACCESS AND THERE'S OTHER RESOURCES WE HAVE ON VITAMIN D. AND THE TABLE OF CONTENTS LETS YOU JUMP TO VARIOUS SECTIONS OF INTEREST. MOST FOLLOW A SIMILAR FORMAT AND ORGANIZATION. FOR EXAMPLE, AND THERE'S RDAs OR THE ADEQUATE INTAKES, AIs FOR A GIVEN NUTRIENT. IT INCLUDES A TABLE OF COMMON FOOD SOURCES AND THE AMOUNT OF THE NUTRIENT IN THIS CASE, VITAMIN D PER SERVING ON THE RIGHT AND ALSO PER SERVING THE PERCENT OF DAILY VALUE WHICH IS WHAT YOU SEE ON FOOD AND SUPPLEMENT LABELS. IN MOST CASES WE TAKE THIS FROM THE USDA FOOD CENTRAL DATABASE BUT WILL SITE OTHER SOURCES FROM THE SCIENTIFIC LITERATURE AS WELL WHEN THAT'S AVAILABLE AND WE DISCUSS BIO AVAILABILITY SINCE OXILATES CAN INHIBIT ABSORPTION AND WE SEARCH FOR VARIOUS HEALTH OUTCOMES. IN VITAMIN D THE PRIMARILY IS BONE HEALTH BUT OTHER HEALTH RELATED CONDITIONS AS WELL. EACH SECTION IS SEVERAL PARAGRAPHS LONG SO A HEALTH CARE PROVIDER OR RESEARCHER CAN QUICKLY GET A FEEL FOR THE LEVEL OF EVIDENCE OR ANY BOTTOM LINE OR RECOMMENDATIONS OR EXPERT BODIES AND CAN REFER TO THE REFERENCES FOR MORE DETAILS. AND BECAUSE MEDICATION INTERACTIONS ARE AN IMPORTANT CONSIDERATION WITH DIETARY SUPPLEMENTS, WE DEVOTE A SHORT SECTION IN ALL OF OUR FACT SHEETS TO INTERACTIONS WITH COMMON MEDICINES. ESPECIALLY WHEN THE RESULT MAY BE CLINICALLY SIGNIFICANT AND INCLUDE INTERACTIONS THAT AFFECT THE ACTION OF THE MEDICATION AS WELL AS THOSE THAT CAN INCREASE OR DECREASE NUTRIENT LEVELS IN THE BODY. AND OF COURSE OUR NUTRIENT FACT SHEETS ADDRESS THE TOLERABLE UPPER INTAKE LEVELS OR ULs AND DESCRIBE THE POTENTIAL ADVERSE HEALTH AFFECTS FROM TAKING TOO MUCH OF THE INGREDIENT. HERE'S FACT SHEET IN ENGLISH AND SPANISH AND PROVIDE THEM IN HTML FORMATS AND THESE CAN BE PRINTED AND A HSHG PROVIDER CAN USE THEM AS HAND OUTS. NOW I'LL TURN THINGS OVER TO CAROL WHO WILL TALK ABOUT OUR OTHER FACT SHEETS AND RESOURCE. >> I'VE CAROL HAGGANS AND I WANT TO INTRODUCE OUR MOST RECENT FACT SHEETS AND WE KNOW INTEREST IN DIETARY SUPPLEMENTS DURING THIS TIME REMAINS HIGH EVEN THOUGH SUPPLEMENTS ARE NOT INTENDED TO PREVENT OR TREAT DISEASE. IT PROVIDES DETAILED INFORMATION ON 15 INGREDIENTS CITING COMPLETED RESEARCH AS WELL AS IN PROCESS CLINICAL TRIALS AND THE BOTTOM LINE IS THE DATA ARE CURRENTLY INSUFFICIENT TO SUPPORT RECOMMENDATIONS ONE WAY OR THE OTHER FOR ANY DIETARY SUPPLEMENT TO PREVENT OR TREAT COVID-19 BUT DID THINK IT WOULD BE HELP IT WILL TO SUMMARIZE WHAT WE KNOW AND DON'T KNOW ABOUT EACH OF THESE INGREDIENTS. FOR EXAMPLE, HERE'S THE SUMMARY FOR OMEGA 3s BEING STUDIED FOR THE POTENTIAL AFFECTS ON THE INFLAMMATORY RESPONSE AND IMMUNE SYSTEM. IT SUMMARIZES SOME RESEARCH ON THE EFFICACY OF OMEGA 3s INCLUDING LINK TO SOME IN PROCESS CLINICAL TRIALS AND ALSO BRIEFLY DISCUSSES SAFETY CONSIDERATIONS. HERE'S AN EXAMPLE WE LINKED TO FROM OUR FACT SHEET. IT'S LISTED IN CLINICALTRIALS.gov AND LOOKED AT THE CYTOKINE STORM BUT THE STUDY FINDING NOT YET AVAILABLE AND WE HAVE OTHER RESOURCE. ONE IS A LIST OF FREQUENTLY ASKED QUESTIONS LIKE HOW DO I KNOW IF I NEED A DIETARY SUPPLEMENT AND I'M TRAINING FOR A MARATHON AND WONDER IF TAKE CREATINE SUPPLEMENT AND THINGS LIKE CAN ZINC MAKE THEIR HAIR GROW AND SOME PEOPLE LIKE INFORMATION FROM VIDEOS SO WE PRODUCED A FEW VIDEOS AND THEY HAVE 94,000 VIEWS. AT THE END OF OUR PRESENTATION WE'LL PLAY ONE OF THESE SHORT VIDEOS FOR YOU. IT'S CALLED DIETARY SUPPLEMENTS, WHAT YOU NEED TO KNOW. WE EMPHASIZE THE IMPORTANCE OF TALKING TO YOUR HEALTH CARE ADVISER FOR ADVICE. ONE REASON IT'S IMPORTANT TO HAVE THE CONVERSATION IS THE POSSIBILITY OF MEDICATION INTERACTION. WE CREATED AN EASY TO USE SUPPLEMENT AND MEDICINE RECORD FOR PEOPLE TO KEEP TRACK OF WHAT WHAT THEY'RE TAKING AND OLDER ADULTS TAKE NUMEROUS SUPPLEMENTS AND MAY BE MORE COMFORTABLE WITH A PRINTABLE FORM INSTEAD OF AN APP ON THEIR PHONE. THIS AVAILABLE IN SPANISH AS WELL. WE HAVE A RESOURCE INCLUDING ALL OF OUR DIETARY SUPPLEMENT FACT SHEETS. WE ALSO HAVE A MONTHLY SEMINAR SERIES ORGANIZED BY BARBARA SORKIN WHO YOU HEARD FROM EARLIER IN THE SYMPOSIUM. BETWEEN 2017 AND 2020, ODS HOSTED 36 SEMINAR SPEAKERS ON A VARIETY OF TOPICS. A FEW WEEKS AGO WE HEARD OF DR. BOUCHER FROM THE UNIVERSITY OF HAWAI'I CANCER CENTER FOR CAPTURING FOOD, BEVERAGE AND SUPPLEMENT INTAKES WITH TECHNOLOGY LIKE TAKING PICTURES TO MORE ACCURATELY ESTIMATE INTAKES AND WE'LL HEAR FROM DIET AND MICROBIOME INTERACTION AND ALL OUR SEMINAR FREE OF CHARGE AND OPEN TO ANYONE. MANY LIKE TO RECEIVE NEWSLETTERS TO KEEP THEM UP TO DATE. THERE'S NEWSLETTERS THAT SUMMARIZE RECENT RESEARCH FINDINGS AND ANSWER COMMONLY AND WORK SHOPS AND SEMINARS AND CONFERENCE. ONE OF OUR NEWSLETTERS IS THE ODS UPDATE INTENDED FOR HEALTH S AND HAVE A SPECIAL SUPPLEMENT FOR VARIOUS ANNOUNCEMENTS FROM OUR OFFICE. WE HAVE A NEWSLETTER CALLED THE SCOOP AND IT HAS MORE THAN 26,000 SKRUBSCRIBERS AND THIS ADDRESSES QUESTIONS LIKE WHAT HAPPENS IF I DON'T GET ENOUGH VITAMIN B12 AND THE DOCTOR RECOMMENDED ONE BECAUSE OF MY AGE, WHY IS THAT? IF YOU'D LIKE OTHER INFORMATION FROM OUR OFFICE OR WANT NEWSLETTERS JOIN THE ODS E-MAIL LIST VIA OUR WEBSITE. WHEN YOU JOIN, YOU CAN CHOOSE FROM A LIST OF SUBSCRIPTION TOPICS DEPENDING ON YOUR AREA OF INTEREST INCLUDING TOPICS SUCH AS THE ANALYTICAL METHODS AND REFERENCE MATERIALS PROGRAM ADAM KUSZAK PRESENTED ON AND SUPPLEMENTARY INGREDIENT DATABASES OTHERS SPOKE ABOUT AND PROGRAMS AND INITIATIVES COVERED DURING THE SYMPOSIUM AND SPECIFIC DIETARY SUPPLEMENTS AND STARTED USING GOV DELIVERY TO MANAGE OUR E-MAIL LIST TO HELP INCREASE OUR REACH. ODS ALSO HAS A SOCIAL MEDIA PRESENTATION AND FOLLOW US ON FACEBOOK AND TWITTER AND WE POST ONES A DAY AND REPOST AND RE RETWEET RELATES AND ONCE A WEEK WE POST IN SPANISH AND CURRENTLY HAVE OVER 10,000 FOLLERSSS -- FOLLOWERS ON FACEBOOK. IF YOU WANT TO MAKE A COMMENT OR SUGGESTION, YOU CAN E-MAIL US. WE CAN'T OFFER MEDICAL ADVICE, OF COURSE, BUT WE DO RESPONSE TO EACH INQUIRY WE RECEIVE AND LAST YEAR WE RESPONDED TO 539 INQUIRIES AND USUALLY RESPOND FAIRLY QUICKLY WITHIN A FEW DAYS. THERE'S BEEN MEDIA INQUIRIES AND WE HAVE RESOURCES. VARIOUS ODS STAFF HAVE BEEN GIVEN INTERVIEWED AND QUOTE THE NEW YORK TIMES AND WASHINGTON POST AND WALL STREET JOURNAL AND CNBC AND PREVENTION MAGAZINE AND THE SATURDAY EVENING POST, WIRE MAGAZINE AND RUNNER'S WORLD AND A VARIETY OF WEB ONLY PUBLICATIONS WITH NAMES LIKE ROMPER AND INVERSE AND OCCASIONALLY GET UNUSUAL REQUESTS FROM A JOURNALIST FROM A CULTURE SHOW AND ONE QUESTION WAS RELATED TO THE DISCOVERY OF FOLIC ACID AND WANTED TO MAKE SURE THEIR QUESTION AND ANSWERS WERE ACCURATE AND PROPERLY WORD WORDED SO WE HELPED THEM OUT WITH THAT. WE ALSO LIST ODS STAFF PUBLICATION AND PRESENTATIONS. OUR STAFF HAS BEEN BUSY BETWEEN 2017 AND 2020, ODS STAFF GAVE 146 PRESENTATIONS AT NATIONAL AND INTERNATIONAL CONFERENCES AND AUTHORED 155 PUBLICATIONS. AND NOW I'LL TURN IT BACK TO PAUL WHO WILL GO THROUGH A FEW OTHER RESOURCES. >> THANKS. ON OUR WEBSITE PROVIDES MANY LINK TO OUR RESOURCES INCLUDING OUR DATABASES AND POPULATION STUDIES PROGRAM AND OUR IODINE, IRON AND VITAMIN D INITIATIVES. AND WE RECENTLY ADDED NEW WEB PAGES FOR OUR CARBON BOTANICAL RESEARCH PROGRAM AND A TRANS NIH RESILIENCE WORKING GROUP. PART OF THE ODS MISSION BY CONGRESSIONAL INTENT IS TO ADVISE HHS AND NIH ON DIETARY SUPPLEMENT ISSUES. WE'VE DONE THAT BUT WE'VE EXPANDED OUR REACH. ODS ALSO INTERACTS WITH REPRESENTATIVES FROM AGENCIES AND OFFICES THROUGHOUT THE FEDERAL GOVERNMENT TO SHARE INFORMATION AND TO DISCUSS ISSUES TO STUDY TO IDENTIFY RESEARCH NEEDS AND TO DETERMINE WHAT RESOURCES MIGHT BE CREATED TO FURTHER THE SCIENCE AND EDUCATION ON DIETARY SUPPLEMENTS. AND SINCE 2005, ODS HAS MET TWICE A YEAR WITH THESE REPS IN A STRUCTURE WE KNOW HAVE NAMED THE FEDERAL WORKING GROUP ON DIETARY SUPPLEMENTS. AND ORIGINALLY ITS REPRESENTATIVES WERE FROM NIH BUT EXPANDED TO INCLUDE THE ENTIRETY OF THE INTERESTED FEDERAL GOVERNMENT. TODAY THIS GROUP HAS MEMBERS FROM THE NIH OF COURSE AND SOME TWO DOZEN FEDERAL AGENCIES AND OFFICES INCLUDING THE U.S. DEPARTMENT OF AGRICULTURE, DEFENSE, JUSTICE, VETERANS AFFAIRS AND INDIAN HEALTH AND THE FEDERAL TRADE COMMISSION AND EVEN NASA. AND FINALLY, IF YOU'RE A RESEARCHER YOU MAY BE INTERESTED IN OUR GRANTS AND FUNDING WEB PANEL. IT INCLUDES OUR RESEARCH PORTFOLIO TO DETAIL THE STUDIES WE FUND EACH YEAR ALL THE WAY BACK TO 1996 AND ALSO PROVIDES INFORMATION ABOUT OUR VARIOUS FUNDING OPPORTUNITIES AND ANNOUNCEMENTS INCLUDING ANSWERS TO GENERAL QUESTIONS ABOUT NIH FUNDING AND ADMINISTRATIVE SUPPLEMENTS. SO THAT'S OUR BRIEF OVERVIEW OF OUR COMMUNICATION EFFORTS AND RESOURCE. CONTACT US IF YOU THINK WE MAY BE ABLE TO HELP YOU RELATED TO DIETARY SUPPLEMENTS. NOW TO FINISH UP OUR TALK WE'D LIKE TO PLAY ONE OF OUR ODS VIDEOS. IT'S A SHORT TWO-MINUTE VIDEO ABOUT DIETARY SUPPLEMENTS AND WHAT TO CONSIDER BEFORE TAKING THEM. LET'S HOPE THIS WORKS. >> SHOULD I TAKE THE DIETARY SUPPLEMENT? HOW DO I KNOW HOW MUCH TO TAKE? CAN VITAMIN C PREVENT COLDS? CAN I TAKE ST. JOHN'S WART WITH MEDICATIONS? WHERE CAN I GET RELIABLE ANSWERS? >> PEOPLE HAVE QUESTIONS ABOUT DRINK AND ENERGY BARS. YOU CAN GET ALL THE VITAMINS AND MINERALS YOU NEED FROM THE FOODS YOU NEED BUT NOT EVERYONE EATS AS WELL AS THEY SHOULD. MANY PEOPLE WONDER IF THEY SHOULD TAKE A SUPPLEMENT LIKE A MULTI-VITAMIN. RESEARCH SHOWS SOME DIETARY SUPPLEMENTS ARE BENEFICIAL. TAKING FOLIC ACID HELPS PREVENT BIRTH DEFECTS AND CALCIUM AND VITAMIN D CAN IMPROVE BONE HEALTH. SOME NEED TO BE STUDIES TO LEARN WHETHER THEY'RE SAFE AND EFFECT ITCH. MANY ARE MADE FROM NATURAL INGREDIENTS THAT COME FROM PLANT AND ANIMALS BUT NATURAL DOESN'T ALWAYS MEAN SAFE. THERE'S TENS OF THOUSAND OF DIETARY SUPPLEMENTS ON THE MARKET. IT'S IMPORTANT TO BE INFORMED. TALK TO YOUR HEALTH CARE PROVIDER ABOUT DIETARY SUPPLEMENTS AND DISCUSS WHAT IS SAFE FOR YOU AND IF THEY CAN INTERACT WITH MEDICATION. WE'RE AT THE NATIONAL INSTITUTES OF HEALTH. WEBB -- WEBSITE TO FIND OUT WHAT YOU NEED TO KNOW ABOUT DIETARY SUPPLEMENTS. >> THANK YOU. >> NOW WE HAVE TIME FOR A LITTLE BIT OF A BREAK AND REPORT BACK AT 2:35 P.M. AND WE'LL MOVE ON TO TRAINING THE NEXT GENERATION OF DIETARY SUPPLEMENT RESEARCHERS. THANK YOU. WE'LL SPRINT TOWARDS THE END WITH A VIDEO PRESENTATION FROM DR. JAIME GAHCHE THE DIRECTOR OF THE MARY FRANCIS PRACTICUM. >> I'M HAPPY TO BE HERE TO DISCUSS SOME ACTIVITIES WE DO AT ODS TO ENHANCE THE DIETARY RESEARCH. THIS IS ONE OF THE MAIN GOALS OF ODS AND DO THIS IN SEVERAL WAYS. WE DO THIS BY USING THE NIH GRANT AWARDS THAT SERVE THE EXTRAMURAL COMMUNITY. ONE EXAMPLE IS THROUGH ADMINISTRATIVE SUPPLEMENT WHICH PROMOTES DIETARY SUPPLEMENT BY ADDING SUPPLEMENTAL FUNDS TO EXISTING NIH GRANTS. THESE ADMINISTRATIVE SUPPLEMENTS PART OF THE CO-FUNDING PROGRAM WITH NIH INSTITUTES AND CENTERS PERMITS INCORPORATION OF RESEARCH WITHIN THE SCOPE OF A GRANT THAT OTHERWISE WOULD NOT BE FUNDED. AND OF COURSE ALSO INCLUDES EARLY CAREER SCIENTISTS. THE PROGRAM ALSO HELPS TRAIN INVESTIGATORS TO CONDUCT RESEARCH ON SUPPLEMENTS THEREBY BUILDING FISCAL CAPACITY. IN FISCAL YEAR 2020 ODS FUNDED SUPPLEMENTS AT MORE THAN $3.5 MILLION AND SPONSORS INTRAMURAL SCHOLARS AWARDS WITH INSTITUTES AND CENTERS AND I'LL PROVIDE MORE DETAIL ABOUT THE PROGRAM IN THE NEXT FEW SLIDES. ANOTHER WAY WE DEVELOP THE WORKFORCE IS BY COLLABORATING WITH OTHER AGENCIES TO SUPPORT, MENTOR AND PROVIDE TECHNICAL GUIDANCE TO POST-DOC FELLOWS AND EARLY CAREER SCIENTISTS. FOR EXAMPLE, OVER THE YEARS WE HAVE FUNDED POST-DOCS AT THE NATIONAL INSTITUTES OF STANDARDS AND TECHNOLOGY AS WELL AS THE U.S. DEPARTMENT OF AGRICULTURE. ODS ALSO OFFERED SHORT TERM TRAINING OPPORTUNITIES FOR STUDENTS AND FACULTY MEMBERS. WE'VE HAD A GREAT OPPORTUNITY TO HAVE FELLOWS COME AND TRAIN AT ODS AND FINALLY WE HOST THE MARY FRANCIS PICCIANO DIETARY SUPPLEMENT RESEARCH PRACTICUM AND FIRST I'D LIKE TO FOCUS ON THE ODS RESEARCH FOL -- FELLOW RESEARCH PROGRAM AND IT'S AN OPPORTUNITY FOR NIH INTRAMURAL SCIENTIST TO STUDY THE ROLE OF DIETARY SUPPLEMENTS IN DISEASE PREVENTION. ODS STARTED THIS PROGRAM IN 20 1457BD -- 2014 AND GOES TO TENURE TRACK INVESTIGATORS AND RESEARCH FELLOWS AND POST-DOCTORAL FELLOWS. PROJECTS GO TO ONE-YEAR OF FUNDING AND IT'S TO DESIGN THE PROJECTS TO BE CARRIED OUT IN A SHORT PERIOD OF TIME WITH LIMITED RESOURCES. PRIMARY CONSIDERATION FOR SUPPORT IS GIVEN TO PROPOSALS THAT STIMULATE DIETARY SUPPLEMENT RESEARCH WHERE THERE ARE GAPS, INVESTIGATE THE BALANCE BETWEEN HEALTH BENEFITS AND RISK WHERE DATA ARE IN CONFLICT. TARGET SPECIAL POPULATION GROUPS WHERE ADDITIONAL SCIENCE ON SUPPLEMENTS IS REALLY NEEDED AND FOCUS ON THE USE OF SUPPLEMENTS AND THEIR INGREDIENTS AND IMPROVING OR MAINTAINING HEALTH AND REDUCING THE RISK OF CHRONIC DISEASE ANOTHER GOAL IS TO ENHANCE BETWEEN RESEARCHERS FROM DIFFERENT NIH LABORATORIES OR INSTITUTES. AND ALSO AND PRIORITY FOR SCOL SCHOLARS TO LEARN AND APPLY NEW METHODOLOGIES TO HIS OR HER RESEARCH. ONE OF THE REQUIREMENTS OF THE PROGRAM IS FOR THE SCHOLARS TO PRESENT FINDINGS ABOUT A YEAR LATER AT THE ODS SCHOLARS SYMPOSIUM HOSTED BY ODS RESEARCHERS TO PRESENT THEIR FINDING TO ODS AND OUTSIDE OF ODS. THERE'S A NUMBER OF APPLICATIONS ODS HAS RECEIVED SINCE 2014 AND THE NUMBER FUNDED. AND IT'S BEEN STEADY FOR THE APPLICANTS FUNDED PER YEAR AND WITH THE EXCEPTION OF A COUPLE YEARS WE TECHNICALLY HAVE ACCEPTED MORE THAN 60% OF APPLICATION. AND LAST YEAR WE RECEIVED SEVEN GREAT APPLICATIONS AND REFUNDED ALL SEVEN. I ALSO WANTED TO MENTION THAT SINCE 2014, ODS HAS FUNDED APPLICATIONS FOR THE SCHOLAR PROGRAM FROM 11 OF THE NIHs 27 INSTITUTES AND CENTERS. OVER THE TIME PERIOD WE HAVE FUNDED MANY GRANTS FROM THE NATIONAL INSTITUTES OF ALLERGY AND INFECTIOUS DISEASES, THE NATIONAL CANCER INSTITUTE, THE NATIONAL HEART, LUNG AND BLOOD INSTITUTE AND TO THE DIGESTIVE AND KIDNEY DISEASES. WE CONTINUE TO REACH OUT TO THE NIH I.C.s TO HOPE THE PROGRAM WILL GROW AND TRAIN MORE AND MORE OF CAREER RESEARCHERS. WE'RE VERY HAPPY TO HAVE TWO PREVIOUSLY AWARD AND THEY'LL BE PRESENTED AFTER. NOW I'D LIKE TO INFORMATION ON OUR ODS ANNUAL RESEARCH PRACTICUM WHICH IS NAMED AFTER MARY FRANCES PICCIANO. SHE WAS A SENIOR NUTRITION SCIENTIST FROM 2001 UNTIL HER DEATH IN AUGUST 2010 AFTER A LONG BATTLE WITH CANCER. SHE LED THE CREATION AND DEVELOPMENT OF THIS PRACTICUM WHICH WAS FIRST HELD IN MAY 2007. AND HAS BEEN HELD EVERY YEAR WITH THE EXCEPTION OF 2015 AND 2020. IT STARTED TO PROVIDE FUNDAMENTAL SCIENTIFIC KNOWLEDGE OF DIETARY S TO ACADEMIC FACULTY AND THEIR ADVANCED STUDENTS. OVER THE YEARS THE PRACTICUM HAS CHANGED AND BEEN SHORTENED OVER TIME AND FOR THE FIRST TIME THIS YEAR, JUST THIS PAST MAY WAS HELD VIRTUALLY AND OPENED TO A BROADER AUDIENCE. THIS PROVIDES OVERVIEW OF SUPPLEMENTS AND SUPPLEMENT INGREDIENTS AND PRESENTATIONS FROM EXPERTS ALL OVER ON FOR EXAMPLE SUPPLEMENT USE IN THE UNITED STATES AND THE MOTIVATIONS WHY PEOPLE ARE USING THEM, PRENNING -- PRESENTATIONS ON THE SCIENTIFIC INVESTIGATIONS TO EVALUATE THE EFFICACY, SAFETY AND VALUE OF THE PRODUCTS FOR HEALTH PROMOTION AND DISEASE PREVENTION AS WELL AS HOW TO CARRY OUT THIS TYPE OF RESEARCH. AND IT INCLUDES PRESENTATIONS FOCUSSED ON TOPICS FOR THAT YEAR. FOR EXAMPLE, THE PRACTICUM IN MAY WE HAD A PRESENTATION IN DIETARY S AND ALSO GET TO HEAR FROM VARIOUS STAKEHOLDERS. FOR EXAMPLE, THE DIETARY SUPPLEMENT TRADE WORDS AND CONSUMER ADVOCACY GROUPS AND MEDIA. THOSE WHO STUDY AND ADVOCATE AND EDUCATE ON DIETARY SUPPLEMENTS. I ALSO WANT TO MENTION THAT PREVIOUS PRACTICUMS HAVE BEEN RECORDED AND ARE AVAILABLE ON THE WEBSITE. THIS SHOWS THE NUMBER OF PARTICIPANT PARTICIPANTS AND IT HAD BEEN HELD AT NIH AND THIS PAST MAY WE HELD IT VIRTUAL AND TON HAVE A VIRTUAL OPTION AND IN HYBRID BE ABLE TO TRAIN AS MANY PEOPLE AS WE CAN. AND THE PRACTICUM IS MOSTLY STUDENTS AND FACULTY FROM THE UNIVERSITY. YET ALMOST 70% OF ATTENDEES FROM 2007 TO 2020. WE'VE ALSO HAD ABOUT 30% COMING FROM OTHER PLACES, THE GOVERNMENT AND DIETARY SUPPLEMENT INDUSTRY, DIETETIC INTERNS FROM NIH, STUDENTS AND HEALTH CARE PROVIDERS. AND FINALLY, I WANTED TO SHOW FINDINGS WITH EVALUATION WE DID YEARS AGO ON PRACTICUM PARTICIPANTS AND WE TRIED TO GATHER INFORMATION ON IF THEY WERE USING INFORMATION THAT THEY LEARNED FROM THE PRACTICUM IN THEIR CAREERS. AND THIS EVALUATION WAS CONDUCTED IN 2012 AND PARTICIPANTS WERE ASKED TO FILL OUT ONLINE FEEDBACK SURVEY. AND WE HAD ABOUT 134 THAT RESPONDED. AND I WANTED TO JUST SHARE A COUPLE FINDINGS. THERE WERE ABOUT 58% OF THE RESPONDENTS STATE THEY'D USED THE INFORMATION IN COURSE MATERIALS AT THEIR UNIVERSITY OR FOR RESEARCH AND OTHERS REPORTED WORKING WITH OTHER PRACTICUM ON RESEARCH COLLABORATIONS, CO-AUTHORING PAPERS AND CONSULTATION ON PRODUCTS. THE FINDINGS WERE POSITIVE AND INDICATED PAST PARTICIPANTS WERE USING INFORMATION THEY USED IN THE PRACTICUM IN THE CURRENT POSITION. THIS CONCLUDES MY TALK FOR ANYONE INTERESTED IN MORE INFORMATION AND THERE'S DETAILS ON OUR GRANTS AND FUNDING PROGRAMS, OUR ODS SCHOLARS PROGRAM AND MORE INFORMATION ON DIETARY SUPPLEMENT RESEARCH PRACTICUM WHICH WE PLAN TO HOST MAY 23 TO MAY 25, 2022 AND SIGN UP FOR OUR LIST SERVE TO GET UPDATES ON THESE PROGRAMS. THANK YOU. >> I'D LIKE TO INTRODUCE TWO FORMER SCHOLARS. KATIE O'BRIEN IS A RESEARCH SCIENTIST AND WAS AN ODS SCHOLAR IN 2015 AND THE SECOND SCHOLAR IS DR. YANG WHO IS CURRENTLY A RESEARCH FELLOW AT NHLBI AND SHE WAS AN ODS FELLOW IN 2016. DR. O'BRIEN. ARE READY TO SHARE? IF NOT WE CAN GO TO DR. YANG. >> WE'RE HAVING A COUPLE TECHNICAL DIFFICULTIES. YEAR GETTING DR. O'BRIEN LINED UP NOW. >> THANK YOU. >> I'M KATIE O'BRIEN AT THE INSTITUTE OF NATIONAL HEALTH SCIENCES WHERE I WORK ON THE SISTER STUDY AND TWO TIME RECIPIENT OF THE SCHOLARS PROGRAM AWARD AND I'LL GO BRIEFLY THROUGH BOTH PROJECTS WHICH ARE INTERRELATED. AND ALL THE WORK WAS DONE USING DATA FROM THE SISTER STUDY I WILL INTRODUCE IN A LITTLE BIT. THE MOST RECENT FUNDED PROJECT WAS VITAMIN D AND RISK OF BREAST CANCER BY RACE AND ETHNICITY. MANY ARE FAMILIAR WITH VITAMIN D BUT JUST IN CASE YOU AREN'T, WE GET MOST OF OUR VITAMIN D FROM THE SUN. UVB RADIATION STIMULATES A CHEMICAL REACTION AND CONVERTS TO VITAMIN D 3 AND WE GET A LARGE AMOUNT FROM OUR DIET INCLUDING SALMON AND OTHER FATTY FISH. IN THE U.S. WE FORTIFY THINGS LIKE MILK AND ORANGE JUICE AND MOST INCLUDE VITAMIN D AND PEOPLE WHO TAKE IT ALONE OR VITAMIN D PLUS CALCIUM. REGARDLESS OF THE SOURCE IT'S CONVERTED IN THE LIVER TO 25 HYDROXY VITAMIN D OR 25OHD AND CONSIDERED THE MOST BIOMARKER FOR EXPOSURE AND TENDS TO BE A QUICK NOTE THAT 25 OHD IS PRESENT IN BREAST TISSUE SO MAY BE IMPORTANT FOR CARCINOGENIC ACTIVITIES OCCURRING IN THE BREAST TISSUE ITSELF. 25 OHD IS CONVERTED IN THE KIDNEY AND THAT IS THE ACTIVE FORM AND PLAYS A ROLE IN CALCIUM AND PHOSPHORUS AND IN THE BODY AND SOMETIMES CONSIDERED A POSSIBLE BIOMARKER. VITAMIN D IN HEALTH THE ACTIVE FORM HAS ANTICARCINOGENIC PROCESSES AND SIGNALLING PATHWAYS INCLUDING ESTROGEN METABOLISM WHICH IS ANOTHER POTENTIAL LINK TO BREAST CANCER. WE KNOW IT'S BEEN ASSOCIATED WITH OVERALL MORTALITY, LOWER OVERALL MORTALITY AND REDUCED RISK OF MANY CHRONIC DISEASES INCLUDING COLORECTAL CANCER. THE RELATIONSHIP WITH BREAST CANCER IS CONSIDERED NOT ESTABLISHED. IN THE U.S. ABOUT 42% OF WOMEN ARE CONSIDERED VITAMIN D DEFICIENT. HERE THIS LEVEL IS LESS THAN 25 NANOGRAMS PER MILL BASED ON NHANES DATA. AND OVERALL VITAMIN D IS CONSIDERED TO BE AN EASY CHEAP AND PREVENTIVE AGENT FOR SEVERAL DISEASES POSSIBLY INCLUDING BREAST CANCER. AND THE FIRST OF THE TRIALS WAS THE WOMEN'S HEALTH INITIATIVE WHERE THEY RANDOMIZED WOMEN TO CALCIUM COMPARED TO PLACEBO AND THEY OBSERVED 1,000 BREAST CANCER CASES AND HAZARD RATIO ALMOST PERFECTLY NUL. VITAL TRIAL IS MORE RECENT AND RANDOMIZED WOMEN TO 2000 IUs AND HAVE SIMILAR RESULTS WITH 246 BREAST CANCER CASES. IN BOTH CASES PEOPLE WERE ALLOWED TO TAKE PERSONAL SUPPLEMENTS AND IN THE CASE OF WHI, 70% OF WOMEN DID SO WHICH YOU CAN IMAGINE CAN MAKE AN IMPACT ON THE STUDY RESULT. THERE'S AN INTERESTING RE-ANALYSIS SHOWING AMONG THOSE NOT TAKING PERSONAL SUPPLEMENTS THERE WAS A STRONG PROTECTIVE EFFECT OF BEING RANDOMIZED TO VITAMIN D. I HAVEN'T SEEN A COMPREHENSIVE ANALYSIS BUT THIS IS CONSIDERED A LOW POWERED ANALYSIS FOR THIS SPECIFIC OUTCOME. A COUPLE OF THESE TWO STUDIES DON'T REALLY SUM UP WHETHER VITAMIN D IS RELATED TO BREAST CANCER AND IN LOOKING AT THE SISTER STUDY, THIS WAS GIVEN IN 2016, I BELIEVE AND HERE I FOUND THAT REGULAR VITAMIN D SUPPLEMENT USE TAKING IT AT LEAST FOUR DAYS A WEEK WAS AGE ASSOCIATED WITH AN 11% REDUCTION IN BREAST CANCER OVER THE FIVE YEARS OF FOLLOW-UP. GETTING AT THE IDEA THAT RECENCY MATTERS AND SOMETIMES EFFECTS GET WASHED OUT OVER TIME AND WE NEED TO FOCUS ON RECENT INTAKE OF VITAMIN D. THE SECOND PART OF THE STUDY WAS TO LOOK AT 25 OHD MEASURES AND HERE'S MY RESULTS. I SHOWED THAT LEVELS IN THE FOURTH QUARTILE OF THE NANOGRAMS PER MILL WERE ASSOCIATED WITH A REDUCED RISK OF BREAST CANCER OVER FIVE YEARS COMPARED TO LEVELS IN THE LOWEST QUARTILE LESS THAN 24.6 NANOGRAMS PER MILL AND THIS IS ASSOCIATION WAS PARTICULARLY STRONG AMONG POST MENOPAUSAL WOMEN. THE ONE THING ABOUT THE WORK IS THERE WAS SMALL NUMBER OF MINORITY WOMEN IN THIS GROUP. AND FOCUSSING IN ON THE BLACK AFRICAN AMERICAN WOMEN AND HAD 121 CASES AND 122 IN A SUB COHORT. NOT REALLY STRONG NUMBERS AND COULDN'T REALLY STRATIFY EFFECTS. THE REASON WHY I MIGHT CARE ABOUT RACE, ETHNICITY, STRATIFIED EFFECTS AND THERE'S EXPOSURE BY RACE AND ETHNICITY. THIS IS LOOKING AT SUPPLEMENT USE ON THE LEFT AND VITAMIN D SUPPLEMENT USE EXCLUDING MULTI-VITAMIN GROUP ON THE GRAPH AND NON-HISPANIC WHITE WOMEN ARE MORE LIKELY TO TAKE SUPPLEMENT THAN THE OTHER GROUPS AND RESPONDED TO THEIR LEVELS WHERE WE SEE THAT LIGHT INDIVIDUALS ARE MUCH LESS LIKELY TO HAVE VITAMIN D DEFICIENCY AND DARKER SKIN MEANS THERE IS LOWER MELANIN AND LOWER OHD VARIABILITY IN THE LEVEL AND THERE'S IMPORTANT DIFFERENCES BY RACE AND ETHNICITY. ON THE LEFT WE SEE MORTALITY AND INCIDENTS AND AMONG NON-HISPANIC BLACK WOMEN MORTALITY IS PARTICULARLY HIGH DISPIT THE FACT THAT NON-HISPANIC WHITE WOMEN HAVE HIGHER INCIDENTS OF BREAST CANCER AND WE THINK THIS DISPARITY IS DRIVEN BY LARGE DIFFERENCES IN WHAT BREAST CANCER SUBTYPES. BLACK WOMEN AND TO SOME EXTENT HISPANIC WOMEN TEND TO GET MORE CANCERS AND LESS TREATABLE MORE AGGRESSIVE FORMS OF THE DISEASE AND MAY CONTRIBUTE TO THE MORTALITY DIFFERENCE AND SOMETHING AS RESEARCHERS WE'RE ALWAYS TRYING TO IDENTIFY FACTORS THAT MAY DIFFER BY SUBTYPE AND THEORETICALLY VITAMIN D COULD BE POTENTIALLY ONE OF THOSE THINGS BY RACE AND ETHNICITY. AIM OF MY MOST RECENT GRANT WAS TO LOOK AT THE LEVELS IN BLACK AND HISPANIC LATINO WOMEN. ONE IS TO LOOK AT THE ASSOCIATION BETWEEN TIME VARYING SUPPLEMENT USE AND BREAST CANCER IN THE SISTER STUDY AND DOES RECENCY OF USE MATTER AND FOR AIM TWO I WANTED TO EXAMINE THE ASSOCIATION BETWEEN CIRCULATING 25 OHD AND BREAST CANCER AMONG BLACK AND LATINO WOMEN IN THE SISTER STUDY AND I MEASURED 25 OHD BUT I WON'T PRESENT THEM BECAUSE THEY'RE LARGELY INCONSISTENT WITH THE 25 OHD RESULTS. THE SISTER STUDY IS A PROSPECTIVE COHORT OF 50,000 WOMEN FROM ALL OVER THE U.S. IN U.S. AND PUERTO RICO AND ALL HAD A SISTER WITH BREAST CANCER BUT NEVER HAD BREAST CANCER THEMSELVES. ON AVERAGE THE WOMEN IN OUR COHORT HAD TWICE THE RISK OF DEVELOPING BREAST CANCER COMPARED TO A SIMILAR GROUP WITH NO FAMILY HISTORY. AT BASELINE THEY COMPLETED COMPUTER TELEPHONE INTERVIEWS INCLUDING FAMILY AND PERSONAL HISTORY WITH AN EMPHASIS ON ENVIRONMENTAL HISTORY AND OCCUPATIONAL EXPOSURES AND DIET AND SUPPLEMENT USE. ALL THE PARTICIPANTS WERE VISIT IN THEIR HOME BY EXAMINERS WHO TOOK BLOOD AND SAMPLES AND BODY MEASUREMENT. OUR WOMEN WERE ABOUT 56 YEARS OF AGE ON AVERAGE AT BASELINE AND A PREDOMINANTLY NON-HISPANIC COHORT WITH 83% IN THE GROUP AND HAD BLACK OR HISPANIC WOMEN ALL SELF-IDENTIFIED AN 2500 NON-BLACK OR LATINO WOMEN. IT'S A WELL EDUCATED GROUP WITH 51% HAVING A BACHELOR'S DEGREE OR HIGHER. THIS IS BASELINE AND RECONTACTED THE WOMEN ONCE A YEAR FOR UPDATES AND MORE EXTENSIVE UPDATES ABOUT EVERY THREE YEARS. EACH FOLLOW UP INTERVIEWS AS SHOWN BY THE TIME LINE HERE WE COLLECTED LOTS OF DETAILED DATA THAT INCLUDED VITAMIN D SUPPLEMENT USE AND HAVE UPDATED IT OVER TIME. AND SO AT THIS POINT WE HAVE NINE YEARS OF FOLLOW-UP AT WHICH 38 BREAST CANCER CASES HAVE DEVELOPED. METHOD FOR THE SUPPLEMENT USE ANALYSIS CONSIDERED TIME VARYING ANALYSES AND I HAVE A FEW QUICK DEFINITIONS HOW THEY HAVE CALCULATION. THE USE IS CONSIDERED CUMULATIVE USE STARTING AT BASELINE. RECENT USE IS USE ACCORDING TO THE LAST COMPLETED QUESTIONNAIRE AND PRIOR USE IS USE ACCORDING TO THE QUESTIONNAIRE BEFORE THAT. AND STRATIFYING THE CYCLE TO LOOK AT RATIOS OF 95% COMPETENCE INTERVALS. AND WE SAW 64% REPORTED A USE OF VIOLATE MIN D SUPPLEMENTS IN SUPPLEMENTS AND VITAMIN D PLUS CALCIUM AND SAW NO ASSOCIATION WITH BREAST CANCER. BREAKING THIS DOWN INTO THE RACE ETHNICITY SPECIFIC ESTIMATES, WE DO SEE AS EXPECTED WHITE WOMEN WERE MORE LIKELY TO REPORT COMPARED TO 56% OF BLACK WOMEN AND 50% OF LA TINAS. WE DO SEE A LITTLE BIT OF VARYING FOR THE RACE SPECIFIC ESTIMATES BUT THE OVERALL HETEROGENEITY DOESN'T SHOW SUBSTANTIAL DIFFERENCES BY RACE. LOOKING AT RECENT SUPPLEMENT USE CONTROLLING FOR PRIOR USE, SAW A REDUCTION IN THE BREAST CANCER ASSOCIATED WITH RECENT USE. AND OVERALL AN 83% IN THE NON-HISPANIC WHITES. WE DON'T SEE BIG DIFFERENCES BY RACE OR ETHNICITY BUT WE SEE SOME REDUCTION IN RISK OVERALL. BREAKING THIS DOWN, THE RECENT SUPPLEMENT USE RESULTS DOWN BY AND WE SAW A SMALL DIFFERENCE IN THE EFFECT BY EVASIVE CARCINOMA WITH STRONGER PROTECTIVE ASSOCIATIONS FOR THE FORMS OF BREAST CANCER WE INCLUDED HERE WHICH MAY GIVE SOME INCLUDE TO THE TIMING AND WHEN THE EFFECTS OF VITAMIN D MAY BE MOST POTENT IN TERMS OF BREAST CANCER RISK. WE SAW NO DIFFERENCES BY ESTROGEN RECEPTOR STATUS. AND WE SAW NO CLEAR DIFFERENCES BY RACE OR ETHNICITY AND NO DIFFERENCES BY ER STATUS BUT POSSIBLE STRONGER ASSOCIATION TO INVASIVE DISEASE. THEN MOVING ON TO AIM 2 LOOKING AT THE CIRCULATING OHD LEVELS AND I LOOKED AT 1800 WOMEN AND THIS WAS LIMITED TO BLACK WOMEN AND LATINAS AND WE HAD A TOTAL OF 290 BLACK CASES AND 125 LATINA CASES AND THESE WERE COMPARED TO RANDOM SAMPLES OF THE COHORT CALLED THE SUBCOHORT. AND I'M LOOKING AT A COMBINATION OF SERUM OR PLASMA DEPENDING ON WHETHER THEY WERE INCLUDED IN THE INITIAL ANALYSIS AND TOTAL OF 25 ODH AND D3 AND D2 AND MEASURED AND THEY'RE ANALYZED USING MODELS. HERE'S OUR DISTRIBUTION OF 25 OHD BY RACE AND THE CUT POINT OF 20 NANOGRAMS TO DEFINE DEFICIENCY AND 18% DEFICIENCY AMONG LATINA WOMEN AND SAW AN OVERALL REDUCTION AND THIS WITH US STRONGER IN THE LATINAS AND WE DIDN'T REALLY SEE STRONG DIFFERENCES HERE. AND FOR THE SUMMARY WE OBSERVED AN INVERSE ASSOCIATION BETWEEN NON-DEFICIENT 25 OHD IN BREAST CANCER IN LATINA AND SAW NO DIFFERENCES IN THE STATUS AND THE QUESTION IS DOES VITAMIN D PROTECT AGAINST BREAST CANCER AND I'LL STILL GIVE IT A MAYBE AND OBSERVED INVERSE ASSOCIATION FOR RECENT SUPPLEMENT USE AND CONSISTENT WITH A PROTECTIVE AFFECT BUT SAW NO CLEAR DOSE RESPONSE AND NO RECENCY EFFECT. WHAT IS THE ROLE OF ETHNICITY IN THIS RELATIONSHIP? BLACK AND AFRICAN AMERICAN AND HISPANIC LATINA WOMEN COMPARED TO WHITE WOMEN ARE LESS LIKELY TO TAKE VITAMIN D CONTAINING SUPPLEMENTS AND WE SAW NO CLEAR DIFFERENCES IN THE MAGNITUDE OF ASSOCIATIONS AND NO CLEARLY LINK BETWEEN VITAMIN D AND SPECIFIC SUB TYPES. WE DON'T THINK IT'S THE BIG SECRET THAT EXPLAINS THE LINK OF THE DIFFERENCE. TO ACKNOWLEDGE THE FUNDING WAS SUPPORT THE SUPPLEMENT RESEARCH SCHOLARS PROGRAM AND THE CO-AUTHORS AND THIS IS THE STUDY RESEARCH. THANK YOU FOR HAVING ME TODAY. >> THANK YOU, DR. O'BRIEN. WHY DON'T WE GO AHEAD WITH DR. YANG'S PRESENTATION AND DO QUESTIONS AT THE END. >> THANK YOU, EVERYONE AND THANK YOU KAREN FOR YOUR WARM INTRODUCTION. CAN ANYONE CAN CONFIRM YOU CAN WATCH THIS. THANKS. I WOULD LIKE TO THANK ODS FOR INVITING ME TO INTRODUCE OUR STUDY ON DIETARY MARINE FATS AND DISEASE PREVENTION AND BEYOND. THERE ARE MORE THAN 20 TYPES OF THESE IN OUR FOODS AND FATTY ASSAY IS IN LIVER OIL AND MAINLY VEGETABLE OILS. MY TALK IS SUPPORTED BY ODS WHILE FOCUSSED ON TOO MUCH STUDY OF ANY ASSAY AND AT THE END OF THIS TALK I THINK YOU'LL HAVE MORE INTEREST IN THEIR USE AS DIETARY SUPPLEMENT FOR TREATING DISEASE AND AGE RELATED OCULAR DISEASE. FIRST I'D LIKE TO INTRODUCE CVD RISK. FISH CONSUMPTION IS RECOMMENDED AND MULTIPLE HUMAN STUDIES HAVE SHOWN RICH FISH DIET IS RELATED TO CVD OUTCOMES. HOWEVER, A RECENT META-ANALYSIS OF 10 TRIALS INVOLVING MORE THAN 77,000 INDIVIDUALS SHOWED NO CORRELATION BETWEEN SUPPLEMENTS AND A MAJOR EVENT. THE STUDY PRESENTED YESTERDAY SHOWED AN INTERESTING AND SIMILAR RESULT. THOUGH FACTORS LIKE DOSAGE AND FORMULATION AND POPULATION NEED TO BE FURTHER STUDIED. WE ALSO ASKED IF THERE WERE ANY OTHER ELEMENTS MISSING BESIDES OMEGA . THIS IS A STUDY BACK IN 1970s THAT FIRST ESTABLISHED A LINK BETWEEN OMEGA 3 INTAKE AND REDUCED CVD RISK. INTERESTINGLY THEY ALSO HAD LCMUFA IN THE TRADITIONAL DIET OF INUIT. AND IT'S ALSO IN EDIBLE FISHES SUCH AS POLLOCK THE PRIMARY TARGET FOR THE FISH INDUSTRY IN THE U.S. AND MACKEREL UP EUROPE AND SAURY. IT CONTAINS 30% OF LCMUFA. MOST CONSUME THE FISH IN THE U.S. AND CONTAIN CONSIDERABLE AMOUNT BESIDES THE OMEGA 3. THUS, WHEN WE EAT FISH WE EAT LCMUFA WITH WELL STUDIED OMEGA 3 LITTLE IS KNOWN ABOUT THE DIETARY AFFECT OF LCMUFA ON CVD RISK. YOU ASK CAN WE GET IT FROM NORMAL FISH OIL SUPPLEMENTS? AND WINTERIZATION IS TO CON TRAIT PUFA AND WE ANALYZED COMMERCIALLY AVAILABLE FISH OIL SUPPLEMENT AND THE CONTENT IS EITHER UNDETECTABLE OR ONLY MILLIGRAM LEVELS IN A TYPICAL ONE GRAM FISH OIL CAPSULE. THERE ARE THE AMOUNT IS USUALLY NOT SUPPLIED BY FORM NORMAL FISH OIL SUPPLEMENTS. THERE WAS A WONDERFUL TALK KNOWN PHYSICIANS HEALTH STUDY AND SHOWED A STRONG CORRELATION BETWEEN RED BLOOD CELLS AND LCMUFA AND CARDIOVASCULAR DISEASE. OUR LONG-TERM FEELING OF LCMUFA RICH DIET IN MICE SHOWED LCMUFA REDUCED THE PLASMA CHOLESTEROL, IMPROVED FATTY LIVER AND GENES ARE INVOLVED IN LIPID AND METABOLISM AND INFLAMMATION. WE FURTHER STUDIED THE AFFECT OF DIETARY LCMUFA ON ATHERO ATHEROSCLEROSIS AND INFLAMMATORY DISEASE OF THE ARTERIES. WE USED TWO ATHEROSCLEROSIS ANIMAL MODELS AND APOE KNOCKOUT MICE AND DISLIPIDEMIA AND IT'S CLOSER TO HUMAN DYSLIPIDEMIA. IN THIS MODEL WE ALSO USED THE OLEIC ACID AND OIL AS COMPARED TO THE LONG CHAIN MUFA. THE HIGHER DOSES DECREASED THE PLASMA TOTAL AND CHOLESTEROL SIGNIFICANTLY IN APOE KNOCKOUT MICE. HOWEVER, A LOWER DOSE DID NOT CHANGE THE PROFILE UP OTHER KNOCKOUT MICE. DESPITE THIS BOTH HIGHER OR LOWER DOSE CHANGED MORE THAN 50% IN BOTH ANIMAL BUT SHORTER CHAIN MUFA DID NOT. CONTRIBUTION OF INFLAMMATION TO ATHEROSCLEROSIS IS SUBSTANTIAL AND DOWNRELATED THE CYTOKINE GENE EXPRESSION AND DECREASED THE INFLAMMATORY CYTOKINE LEVELS. BUT SHORTER CHAIN MUFA DID NOT. OUR ANALYSIS SHOWED UPREGULATION OF THE PASS RATE AND ACTIVATION PPAR HAS BEEN KNOWN TO BE BENEFICIAL TO PROTECT AGAINST ATHEROSCLO ATHEROSCLEROSIS BY INHIBITING INFLAMMATORY PATHWAYS. THE FOLLOWING RTPRC ANALYSIS CONFIRMED THE UPREGULATION AND THE TARGETED GENES OF LIVER IN BOTH ANIMAL MODELS. OMEGA 3 SHOWS ANTI-INFLAMMATORY ACTIONS BY PRODUCING DISTINCT METABOLITES AND OUR METABOLITES INCREASED THE TRANSCRIPTIONAL ACTIVITIES IN HEPATIC CELLS CONTAINING PPAR RESPONSE ELEMENT. PPARs ARE ALSO KNOWN TO PROTECT AGAINST ATHEROSCLEROSIS BY LOOKING AT CHOLESTEROL EFFLUX FROM MACROPHAGE AND THE PLASMA FROM MICE SHOWED THE LCMUFA RICH DIET SIGNIFICANTLY INCREASE THE EFFLUX ABILITY THE METRIC OF FUNCTION FROM BOTH MACROPHAGE AND THE EXPRESSING CELLS AND THE SHORTER CHAIN MUFA DID NOT. THE RECENT PROTEOMIC STUDIES HAVE SHOWN MORE THAN 100 INDIVIDUAL PROTEINS IN THE FRACTIONS MAY BE PROTECTIVE OF CVD RISK. AND OUR PROTEOMICS AND ANALYSIS SHOWED THAT MOST THE SIGNIFICANT CHANGED THEIR PROTEOME BY DIET ARE INVOLVED IN BLOOD COAGULATION LINKED TO ATHEROCLER ATHEROCLEROSIS AND THE ANALYSIS SHOULD GUIDE UP TO 80% OF PROTEOME BY LCMUFA DIET AND RELATED WITH ATHEROSCLEROSIS PROTECTION. THUS, DIETARY LCMUFA CHANGED THE LIPO PROTEIN QUALITY AND REGULATED THE SIGNALLING PATHWAY. BOTH AS A WAY TO HAVE IMPROVEMENT OF ATHEROSCLEROSIS. IN ADDITION, THE CROSS-SECTIONAL STUDIES IN JAPANESE POPULATION SHOWED THE REVERSE CORRELATION BETWEEN CIRCULATING BRFS AND PLASMA CHOLESTEROL LEVELS. AND BASED ON THIS DATA WE CONDUCTED THE FIRST IN HUMAN STUDY OF RICH OIL SUPPLEMENT TO INVESTIGATE THE AFFECT ON LIPO PROTEIN METABOLISM. THIS IS A RANDOMIZED CROSSOVER DOUBLE-BLINDED STUDY. HEALTHY PARTICIPANTS TO TAKE A CONTROL OR LCMUFA SUPPLEMENT FOR EIGHT WEEKS. THEN TAKE THE OTHER PL AS FOR ANOTHER EIGHT WEEKS. THE DAILY DOSE OF THE RICH OIL SUPPLEMENT IS 3.5 GRAMS AND A TOTAL OMIC WERE MATCHED BETWEEN CONTROL AND THE LCMUFA SUPPLEMENT AND OFFERED THE NEW DRUG APPROVAL FROM FDA. THE MAIN LIPO PROTEINS HAVE SUB FRACTIONS VARYING IN THEIR AMOUNT OF RISK. SMALL LDL IS DIFFERENT THAN LARGE LDL. AND OUR RICH OIL SUPPLEMENT DID NOT CHANGE THE HEPATOCYTES BUT CHANGED IT BY 12% COMPARED IT CONTROL OIL. IN CONTRAST, THE CONTROL OIL INCREASED THE LDL CHOLESTEROL MEASURED BY THREE APPROACHES. IN CASE OF HDL, MOST SUBFRACTIONS ARE HIGHLY PROTECTIVE BUT A SMALL HDL MAY BE PROATHEROGENIC AND THE DIET OF SUPPLEMENT INCREASED THE MODEL AND INCREASE THE HDL CHOLESTEROL LEVEL AND EFFLUX ABILITY. THE OIL HAD A SIMILAR AFFECT TO THE TRIGLYCERIDES AND THE PARTICLE COUNTS ESPECIALLY IN HIGHER TERTILE PARTICIPANTS AND HAS BENEFICIAL EFFECT ON PARAMETERS AND THE PLASMA AND TRIGLYCERIDE LEVELS AND FURTHER STUDIES ARE NEEDED TO ASSESS THE IMPACT OF THE LCMUFA RICH OIL SUPPLEMENTATION WITH PATIENTS WITH DYSLIPIDEMIA. THE STUDY LIMITATIONS INCLUDE RELATIVELY SMALL SAMPLE SIZE AND SHORT DURATION AND SINGLE DOSE DESIGN. VERY INTERESTINGLY LATER THIS YEAR ANOTHER RANDOMIZED CONTROL STUDY CONDUCTED BY OUR COLLABORATORS IN JAPANESE POPULATION WITH THE CONTROL AND RICH OIL SUPPLEMENT SHOWED UP IMPROVEMENT OF ENDOTHELIAL FUNCTION IN HEALTHY SUBJECTS WITH THE LCMUFA RICH OIL SUPPLEMENTATION SHOWING INCREASED FLOW DILATION AS A MARKER. THIS IS PARTLY DUE TOTE CHANGE OF THE MICROBIOTA REGULATED AND THE INCREASE. IN VIM, OUR ANIMAL AND HUMAN STUDIES SUGGESTED A BENEFICIAL AFFECT OF DIETARIRY LCMUFA ON CVD RISK. IN THE NEXT FEW SLIDES, I WILL INTRODUCE OUR ONGOING PROJECT. IT'S A PRODUCT OF LONG CHAIN FATTY ACID. IN ADDITION, APE AND DHA SERVES AS PRE CURSORS OF THE LONG CHAIN PUFA. IT WAS FOUND IN RETINA AND BRAIN AND TESTES AND PLAYS A ROLE IN SYSTEMS THAT CANNOT BE FULFILLED BY THE MORE SHORTER TERM FATTY ACID. FOR EXAMPLE, REDUCE PUFA MAYBE AS A COURSE OF A GENETIC EYE DISORDER LEADING TO LOSS WITH AGE GOING ON. YESTERDAY THERE WAS A GREAT TALK ON THE STUDY AND EP AND DHS SUPPLEMENTATION DID NOT ISSUE SIGNIFICANT DEFECT ON MACULAR DEGENERATION. AND RECENT STUDIOS -- STUDIES HAD US ASK IF IT WILL IMPROVE AMD PROGRESSION. AND IT HAS BEEN LARGELY RESTRICTED DUE TO ITS UNAVAILABILITY BY COLLABORATIVE WORKS WITH SEVERAL INDUSTRIES AND WE'RE ABLE TO PRODUCE CONCENTRATE FROM MARINE OILS TO 24, 26 AND 28. IN ADDITION, RECENTLY WE FILED TWO PATENTS ON PRODUCING LARGE PUFA THROUGH CHEMICAL AND BOY LOGICAL APPROACHES. AND THIS DID NOT SHOW ANY TOXICITY IN NORMAL MICE AND LARGE IMPROVEMENT SHOWED AN IMPROVEMENT OF PLASMA PARAMETERS OF LIPID PARAMETERS IN A DOSE DEPENDENT MANNER. AND PUFA DECREASED THE LIPID CONTENT. INTERESTINGLY, A TWO-WEEK PERIOD SHOWED IMPROVEMENT IN RETINAL FUNCTION JUDGED BY THE RESPONSE AND INDIVIDUAL ACUTITY. -- ACUITY AND THIS SHOWED SPECIFIC TISSUES SUCH AS EYE, BRAIN AND LIVERS IN BOTH MALE AND FEMALE MICE WHICH RESULTED IN DISTINCT LIPID REMODELLING. MORE MECHANISMS WILL BE REVEALED BY METABOLOMICS AND THE ANALYSIS. BASED ON THE DATA FROM NORMAL ANIMALS, CURRENTLY WE'RE CONDUCTING SEVERAL ANIMAL STUDIES IN DIFFERENT DECEASED ANIMAL MODELS TO LOOK AT THE PUFA ON CVD AND AMD. AND CVD IS THE LEADING CAUSE OF DEATHS GLOBALLY AND AGE RELATED MACRO DEGENERATION IS THE LEADING CAUSE OF BLINDNESS IN PEOPLE OVER 50 WORLDWIDE. FISH OIL IS THE MOST COMMONLY USED DIETARY SUPPLEMENT IN THE U.S. AND OUR STUDY ON MARINE LCMUFA WERE NOT ONLY EXPAND OUR BASIC SCIENCE AND KNOWLEDGE OF THIS LESS STUDIED FATTY ACID METABOLISM MAY ALSO PROVIDE A SUPPORT FOR DEVELOPING NOVEL FISH OIL SUPPLEMENT AND ENCOURAGING PEOPLE TO INCREASE FISH CONSUMPTION IN A MORE WIDE VARIETY. LAST BUT NOT LEAST I WOULD LIKE TO THANK NIH, ODS FOR THE STRONG SUPPORT ON OUR OMIC LIPID RESEARCH. WE WOULD HAVE NOT BEEN ABLE TO HAVE SO MANY FINDINGS. I'M GRATEFUL MY OUTSTANDING MENTORS AND APPRECIATE OUR INTRAMURAL AND EXTRAMURAL COLLABORATORS. PARTICULARLY I'D LIKE TO THANK DR. EMILY CHU AND THE NATIONAL EYE INSTITUTE WHO INSPIRED US AND CONTINUE TO GIVE US INSIGHTFUL COMMENTS ON THE RESEARCH. I GREATLY APPRECIATE IT. MY TALK IS FINISHED HERE BUT STILL WE HAVE OTHER VERY EXCITING OMIC LIPIDS RESEARCH AND PLEASE FEEL FREE TO CONTACT US FOR MORE INFORMATION. THANK YOU. >> THANK YOU, DR. YANG. DR. BETZ WILL TAKE US TO FINAL QUESTIONS AND DISCUSSION FOR THE END OF THE DAY. >> THANK YOU. I APPRECIATE IT. SO WE ARE IN FACT IN THE FINAL SPRINT TO THE END OF THE DAY. I WILL GIVE JAMES A FEW MINUTES TO MAKE SURE THAT EVERYBODY WHO IS ON THE PANEL FROM THIS MORNING THROUGH THIS AFTERNOON HAS BEEN PROMOTED TO ACTIVATE THEIR MIC AND CAMERA. AND WE CAN KICK OFF RIGHT WITH THE QUESTIONS. I HAVE TO SAY THERE'S BEEN AN EXTRAORDINARY TEAM OF ODS STAFF BEHIND THE SCENES WHO HAVE BEEN KEEPING TRACK OF THE QUESTIONS IN THE QUESTION AND ANSWER BOX AND ALSO IN THE CHAT BOX. AND I'D LIKE TO THANK THOSE DR. ADAM KUSZAK SENT ME A LIST OF TRANSCRIPT OF THE QUESTIONS AND ANSWERS WITH THOSE AND ALSO HIGHLIGHTED THOSE ANSWERED IN THE QUESTION AND ANSWER BOX. I WILL SKIP THROUGH THE ONES ALREADY ANSWERED IN THE QUESTION AND ANSWER BOX OR IN THE CHAT BOX AND I WILL ZERO IN ON THOSE THAT WERE NOT ANSWERED ONLINE FORMAT. SO DR. DEUSTER THERE'S A QUESTION FOR YOU, THE CELLULAR CO-FACTOR THAT CONTRIBUTES TO CELLULAR HEALTH AND RESILIENCE IS THE CHAMPS GROUP ALONGING AT THAT TO SUPPORT THE MILITARY SEVERS -- SERVICE MEN AND WOMEN. >> IT'S ON OUR RADAR. I THINK IT'S VERY INTERESTING AND I KNOW SPECIAL OPERATIONS IS VERY INTERESTED IN THIS AS WELL. BUT YES WE'LL BE DOING THIS IN ANIMAL STUDIES TO BEGIN WITH. >> THANK YOU. WE HAVE A QUESTION FOR DR. DWYER, DR. PEARCE OR OTHERS, HOW DOES ONE GET AN ESTIMATE OF INDIVIDUAL IODINE STATUS USING INDIVIDUAL BIOMARKERS WITHOUT GOING TO AN ENDOCRINOLOGIST. >> I'LL NOTE WE WISH WE HAD AN INDIVIDUAL BIOMARKER. THAT UNFORTUNATELY DOESN'T REALLY EXIST. TO GET A SENSE OF AN INDIVIDUAL'S CHRONIC INTAKE IT'S BEEN ESTIMATED IT TAKES 10 OR 12 IDEALLY WITHIN 24 HOURS AND NOT PRACTICAL SO IT'S AT THE INDIVIDUAL LEVEL. >> DO YOU HAVE ANYTHING TO ADD? >> THERE'S NO SINGLE SIMPLE TEST TO CHECK. ONE CAN STEP BACK AND LOOK AT HABITUAL HABIT. IS THE PERSON A NON-USER OF IODIZED SALT, DID THE PERSON AVOID DAIRY, EGGS, FISH AND IN OTHER WORDS DOES THE DIET TYPICALLY NOT INCLUDE WHAT WE KNOW ARE PRETTY GOOD SOURCES OF IODINE? AND IF THAT'S THE CASE, THEN PERHAPS THE DIETARY SUPPLEMENT MAY BE WORTH DISCUSSING. I THINK YOU HAVE TO TAKE A BIG PICTURE APPROACH TO IT RIGHT NOW BECAUSE WE CAN LOOK THINGS UP IN OUR NEW DATABASE OF COURSE. >> ONE GOOD THINGS THAT'S HAPPENED IS THE INDUSTRY VOLUNTARILY PUT IODINE INTO PRENATALS AND THEY DESERVE A LOT OF CREDIT FOR THAT. NOW IF WE CAN GET IT TO BE WITH EVERY PRENATAL SUPPLEMENT. >> THANK YOU VERY MUCH. ANOTHER QUESTION FOR JOHANNA. WE SHOULD CONSIDER ADDING ROUTINE TESTING CRITERIA SO WE CANNOT OVERDUE IT ON FOLIC ACID. DO WE HAVE HOME URINE OR BLOOD TEST TO RECOMMEND CUSTOM PRENATAL VITAMINS. I SAW YOU ANSWERED IT TO ME BUT WASN'T SURE IF IT WAS PERSONAL OR TO THE GROUP. GO AHEAD. >> I DON'T THINK THAT'S THE WAY TO GO. I THINK WHAT NEEDS TO BE DONE IS RECONSIDER. AND MY COLLEAGUE AND RICH AND I AS WELL AS OTHERS AT NIH AND NICHD WE'VE ALL BEEN THINKING ABOUT THIS BUT THE POINT IS SOME OF THE RECOMMENDATION MADE PARTICULARLY FOR IRON A LONG TIME AGO AND WE KNOW THAT WOMEN HAVE LESS CHILDREN TODAY, A LOT OF PEOPLE ARE ON BIRTH CONTROL PILLS. THERE'S A WHOLE BUNCH OF REASONS WHY WOMEN GO INTO PREGNANCY WITH MUCH BETTER IRON STATUS THAN THEY DID WHEN I WAS FIRST OUT OF GRADUATE SCHOOL. SO THE STANDARDS NEED TO BE BASED ON WHAT'S CURRENT RIGHT NOW IN THE UNITED STATES AND NOT ON TRIALS THAT WERE DONE 20, 30 OR 40 YEARS AGO. THAT'S WHY I COME OUT ON IT. I DON'T THINK THE WAY TO GO IS TRYING TO GET TO PERSONALIZED SUPPLEMENTS AND URINE TESTS. >> THANK YOU. WE HAD A QUESTION FROM A COLLEAGUE WHO SET STANDARDS FOR DIETARY SUPPLEMENTS AND ALSO FOR DRUGS AND HAD ANOTHER QUESTION FOR DR. DWYER WHO SEEMS TO BE IN THE HOT SEAT THIS AFTERNOON. DO WE HAVE CONFIDENCE WHAT'S ON THE LABELS IN THE DSLD ARE ACTUALLY IN THE BOUGHT SIGNAL -- BOTTLE? >> WELL, WE HAVE MORE THAN WHEN ODS WAS ESTABLISHED AND ONE OF THE REASONS WHY WE START THE DIETARY SUPPLEMENT INGREDIENT DATABASE BECAUSE THAT TAKES ANALYTICAL ESTIMATES OF THE AMOUNTS ON THE LABEL BY DOING THE CHEMICAL ANALYSIS. WHAT OUR COLLEAGUES HAVE DONE AT USDA HAVE DONE A REPRESENTATIVE SAMPLE OF THE SUPPLEMENTS THAT ARE ON THE MARKET. I THINK WE'VE GOT A GOOD IDEA HOW BIG THE OVERAGES ARE AND IN SOME CASES IT IS AND SOME IT ISN'T BUT THE USDA HAS DONE GREAT JOB ON THAT. >> I'LL ADD A LITTLE BIT OF INFORMATION. FIRST OF ALL, WE'RE NOT A REGULATORY AGENCY AND WE'RE NOT BIG PRODUCTS OFF THE SHELF AND TESTING IT. THAT'S NOT OUR JOB. WE WORK HARD IN THE DSLD AND DSID AS WELL TO ACCURATELY TO ACCURATELY PRESENT WHAT IS IN THE LABEL IS IN THE BOTTLE AND IN THEORY IF IT'S ON THE MARKET, AS A DIETARY SUPPLEMENT THE LABELLING IS REQUIRED TO BE ACCURATE. INACCURATE LABELS WOULD RENDER A PRODUCT MISBRANDED. THERE ARE SOME CASES WHERE HAVING LESS OR MORE OF A CERTAIN INGREDIENT WOULD RENDER THE PRODUCT ADULTERATED. AGAIN, THAT'S NOT OUR CALL. THEORETICALLY EVERYTHING ON THE MARKET IS ACCURATELY LABELLED BUT THAT'S FDA'S JOB NOT OURS. >> AND NOT ALL LABELLED VERY WELL. THERE'S SPELLING MIST -- MISTAKES AND A BUNCH OF MISTAKES. >> AND ALSO INTERESTING ICE OWE LATES AND THINGS LIKE THAT HAVE -- ISOLATES HAVE EASIER TO INTERPRET THINGS THAN BOTANICAL SO IF IT'S A SINGLE BOTANICALS OR A LABEL WITH SEVERAL BOTANICALS YOU'RE REQUIRED TO NOTE THE AMOUNT OF THE BOTANICAL AND THE SOURCE OF INGREDIENT AND PLANT PAS AND THERE'S A PROPRIETARY CONCEPT FROM FOODS WHERE ONE IS REQUIRED TO LIST THE AMOUNT OF PROPRIETARY BLEND AND IN ANOTHER PART OF THE LABEL ONE IS REQUIRED TO LIST THE COMPONENTS OF THE PROPRIETARY BLEND IN ORDER OF DECREASING PRESENCE IN THE PROPRIETARY BLEND BUT THERE ARE NO QUANTITATIVE UNITS ASSOCIATED WITH THAT. IT'S SIMPLY IF IT'S AN AYOUS -- AQ AQUAEOUS PRODUCT THE FIRST INGREDIENT SHOULD BE WATER AND IT'S AT ISSUE WITH THE INGREDIENT DATABASE BECAUSE IF YOUR TRYING TO MEASURE THE AMOUNT OF PHYTO CHEMICALS AND ALL THAT'S LABELLED IS THE BOTANICAL AND NO PHYTO CHEMICAL CONSTITUENTS LABELLED THEN IT BECOMES DIFFICULT TO DO THAT EVALUATION. KAREN ANDREWS DO YOU WANT TO SAY SOMETHING ABOUT THAT? >> ONE ASPECT IS TOFIDE WHAT THE ISSUES ARE -- TO IDENTIFY WHAT THE ISSUES ARE WITH LABELLING OF THE BOTANICALS AND ENCOURAGE THE LABELS TO BE MORE USEFUL TO CONSUMERS AND ALSO A LOT OF DIETARY INGREDIENTS PROVIDED THROUGH BOTANICALS LIKE GREEN TEA AND TURMERIC AND CRANBERRY, THOSE INGREDIENTS ARE ALSO PROVIDED THROUGH FOODS. IF WE CAN TEST A SIGNIFICANT NUMBER OF THE PRODUCTS WE MAY BE ABLE TO PROVIDE INFORMATION TO HELP WITH INTAKES, TOTAL INTAKES FOR THOSE INGREDIENTS EVEN IF THEY'RE NOT LABELLED ON THE PRODUCTS AND AN ESTIMATE OF WHAT WE'RE SEEING ON AVERAGE OF THE PRODUCTS. >> THE OTHER THING JOE IS THAT IF PEOPLE CALL THE SAME THING, APPLE, ORANGE AND CHERRY, YOU CAN'T PUT THEM INTO A DATABASE. YOU HAVE TO GIVE A STANDARD DEFINITION. THIS IS NOT SOMETHING REQUIRED BY LAW BUT WHATEVER THE DATABASE IS OF THE BIOACTIVES THEY NEED TO GET TOGETHER AND MAKE A COMMON DEFINITION. OTHERWISE YOU CAN'T MAKE A DATABASE OTHERWISE IT'S PUT GOULASH IN THE DATABASE. THANK YOU. THIS IS AN INTERESTING QUESTION. SINCE THE NUMBER AND KIND OF DIETARY SUPPLEMENTS HAS GROWN IN THE LAST DECADE, HAVE AMERICANS' HEALTH IMPROVED? I'M PRETTY SURE THE FACTS ON THIS IS THE AMERICANS OVERALL HEALTH HAS NOT IMPROVED IN THE LAST DECADE. TOO MANY PEOPLE BELIEVE THEY CAN EAT PROCESSED FOODS AND POP VITAMINS AND HAVE GOOD HEALTH. THE EVIDENCE ON THIS IS THERE'S NO SUBSTITUTE FOR ORGANIC QUALITY AND HEALTHY WATER. WHY HAS THERE BEEN SUCH A HUGE INCREASE IN THE NUMBER OF DIETARY SUPPLEMENT. SOME OF THOSE ARE SCIENTIFIC QUESTIONS. SOME ARE SIMPLE STATEMENTS BUT THE FINAL QUESTION IS ESSENTIALLY AN ANTHROPOMORPH ANTHROPOMORPHOLOGICAL APPROACH. >> I DON'T AGREE AT ALL. IF YOU LOOK AT YEARS OF LIFE AFTER AGE 65, IT'S STILL BETTER THAN IT USED TO BE. A LOT OF BETTER THAN IT USED TO BE AND THAT'S WHY IF YOU LOOK AT THE PAPER, THERE'S A WHOLE BUNCH OF PEOPLE DYING AT 95, 103, 102, WHATEVER. WHEN YEARS AGO THEY EVEN HAD A TELEVISION PROGRAM ABOUT LIFE BEGINS AT 80 BECAUSE THEY THOUGHT EVERYBODY OVER 80 WAS SUPPOSED TO BE DEAD OR SENILE. THE CORRELATION OF THE TWO IS NOT VERY GOOD BUT I DON'T THINK IT'S WORSE NOW THAN IT WAS 50 YEARS AGO. I THINK IT'S BETTER. >> THE TIME FRAME THAT WAS PROVIDED BY THE QUESTIONNAIRE WAS 10 YEARS WHICH IS AN EXTRAORDINARILY SHORT AMOUNT OF TIME TO TRY AND MAKE A JUDGMENT LIKE THAT. >> A USEFUL THINGS TO CONSIDER IS WHAT KIND OF MARKET FORCE EFFECT THE LAW HAD IN CHANGING THE DEFINITION AND RELATION OF SUPPLEMENTS IN A FREE MARKET WHICH I WAS GOING TO SUGGEST THERE'S AN ANTHROPOLOGICAL COMPONENT TO THE DEFINITION WHY THERE'S SO MANY SUPPLEMENTS ON THE MARKET. ONE ANSWER IS BECAUSE THERE CAN BE. MY SON HIS SPECIALTY IS IN CONSUMERISM AND SO HE WOULD BE WELL POISED TO WRITE A RESEARCH PAPER ON THAT SORT OF QUESTION BUT HE'S NOT HERE. THAT LEAVES IT TO THE REST OF US TO TRY TO FIGURE OUT. LET'S SEE. TO ALL WHY DO THEY USE RDI ON CHILDREN'S LABEL. >> A LOT OF THEM USE BOTH. THEY'LL SHOW THE PERCENT DAILY VALUE FOR CHILDREN AGED 2 AND 3 AS WELL AS ADULTS AND THE DAILY VALUES FOR THE FDA FOR 3 AND UP. THE ADULTS AND EVERYTHING THOUGH RDs DIFFER THEY PICK ONE VALUE TO APPEAR ON PRODUCT LABELS. MAY HAVE A 6-YEAR-OLD CHILD TAKING A CHILDREN'S VIOLATE MIN AND THEIR DB IS FOR AGES 4 AND UP. IT COMBINES ALL THOSE. I THINK THAT'S ONE OF THE REASONS BUT MOST THE PRODUCTS I'VE SEEN HAVE BOTH. MAYBE YOU'RE AN ADULT TAKING A CHILDREN'S MULTI-VITAMIN AND THAT IS AN FDA REGULATORY QUESTION AND WE DON'T GET INVOLVED WITH LABELLING OR ANYTHING LIKE THAT. >> THANK YOU. ANYBODY ELSE HAVE ANYTHING TO ADD ON THAT? >> WELL, THE ONES WE LOOKED AT ALL HAD LABELLED FOR CHILDREN. SO IT WAS THE CATEGORY UNDER 4 YEARS IN THE STUDIES WE'VE DONE BUT USDA HAS DONE OTHER STUDIES THAT LOOK AT LABEL SOMETIMES WERE DOUBLE LABELLED AS WELL. >> THE ONLY COMMENT I'D MAKE IS WE LOOKED AT CHILDREN'S MULTI-VITAMINS AND LABELLED FOR BOTH OF THOSE TWO AGE GROUPS MENTIONED HOWEVER, THE DIRECTIONS VARIED AND SOMETIMES IT WAS HALF A TABLET FOR TWO TO THREE YEAR OLDS AND A FULL TABLET FOR 3 AND UP AND PEOPLE MAY NOT REALIZE THAT. SOMETIMES IT WAS ONE TABLET AND SOMETIMES IT WAS ONE TABLET FOR ALL OF THE GROUPS. SO I THINK THERE ARE SOME POTENTIAL PROBLEMS WITH THE FACT THAT TWO MEASUREMENTS ARE ON THE LABEL BECAUSE IT CAN BE CONFUSING. >> THANK YOU VERY MUCH. >> DR. DEUSTER HAD A COMMENT. >> I WAS JUST GOING ADD TO THE MARKET PIECE IS THEY KNOW THE MILITARY WILL PARS WHAT I CALL THE BLACK SUPPLEMENTS ARE HEAVILY MARKETED TO THE MILITARY PARTICULARLY FOR PERFORMANCE SO I AGREE WITH YOUR ANALYSIS OF IT IT'S MARKET DRIVEN AND THE MILITARY IS VERY GULLIBLE TO THAT MARKETING. >> THANK YOU. THERE'S BEEN A COUPLE ADDITIONAL QUESTIONS COME IN. ONE I KNOW DR. BROWN WOULD BE VERY INTERESTED IN. ARE VITAMIN D REQUIREMENTS ACROSS DIFFERENT RACES AND ETHNICITIES. LAVERNE, IF YOU'RE ON THE LINE I APPRECIATE YOU HOP IG IN ON THAT AND WE'LL LET OTHER PANELISTS PARTICIPATE AS WELL. >> THANK YOU. THAT'S A TOPIC THEY SPENT SOME TIME TRYING TO BETTER UNDERSTAND. VITAMIN D PARADOX OF BLACK AMERICANS IS AN INITIATIVE THE ODS SPONSORED IN WHICH WE HAD A FORUM AND TALKED THROUGH A GROUP OF EXPERTS THAT STUDIED THE SCIENTISTS AND STUDIED VITAMIN D IN VARIOUS POPULATIONS PARTICULARLY IN BLACK AMERICANS AND IT DOES APPEAR TO BE SOME DIFFERENCES. IT APPEARS AS THOUGH DESPITE THE LOWER LEVELS OF VITAMIN D IN BLACK AMERICANS THAT THE OUTCOMES AND THE SAME NEGATIVE OR ADVERSE OUTCOMES ARE NOT SEEN IN THIS GROUP AND SO SOME OF THE TALKS EARLIER TODAY HIGHLIGHTED THE FACT THAT THERE'S SOME ISSUES WITH HOW WE'RE MEASURING VITAMIN D AND ISSUES ON HOW WE'RE INTERPRETING VITAMIN D STATUSES ACROSS THE BOARD. THOSE ISSUES NEED TO BE RESOLVED BEFORE WE CAN TALK WITH THE DIFFERENT POPULATION GROUPS SUCH AS IN BLACK AMERICANS. >> THANK YOU, LAVERNE. ANYBODY ELSE HAVE ANYTHING TO ADD? >> THE MOST RELIABLE SOURCE OF INFORMATION IS THE NATIONAL ACADEMY OF SCIENCES. FOOD AND NUTRITION BOARD RECOMMENDED DIETARY ALLOWANCES BUT STAY TUNED. THERE'S ALWAYS MORE RESEARCH AND SCIENCE CHANGES. >> WE HAVE A WHOLE ROOM FULL OF NUTRITION AAL EPIDEMIOLOGISTS SO NOW IS THE TIME TO SPEAK. IF NOBODY ELSE HAS ANYTHING ON THIS TOPIC -- >> THIS IS PATSY AND I'D LIKE TO TALK ABOUT IT FROM THE POINT OF VIEW FROM THE DRI AND WE LOOKED AT THE EVIDENCE AND I AGREE WITH ALL THE COMMENTS THAT HAVE BEEN MADE. IT CERTAINLY NEEDS MORE STUDY BUT THE TIME THE DRI COMMITTEE WAS CONSIDERING THE VITAMIN D THERE WAS NOT SUFFICIENT EVIDENCE THERE WAS A DIFFERENCE IN THE VARIATION OF REQUIREMENT AND SO THE DRIs ARE MADE FOR THE GENERAL POPULATION AS A WHOLE WITH NO RACE OR ETHNIC SPECIFIC GUIDELINES. >> IT'S A FIELD THAT FITS IN WITH THE GENERAL OVERALL MISSION OF NIH. BACK IN MY PHARMACY DAYS WE TALKED ABOUT HOW ETHNICITY AND GENETIC FACTORS WOULD AFFECT THE DIFFERENT TENDENCIES TO NUTRITIONAL REQUIREMENTS AND IT'S AN EXCELLENT QUESTION AND ONE WORTH PURSUING GOING FORWARD NOT JUST FOR VITAMIN D BUT FOR ALL NEUTRIENTS AND WE DIDN'T TALK MUCH ABOUT BIO ACTIVES BUT WHEN WE TALKED ABOUT THE BOTANICAL INGREDIENTS WE FORGET SOMETIMES, A, THE DIET IS JUST NOT NUTRIENTS IT'S EVERYTHING WE PUT IN OUR MOUTHS AND SOME THINGS WE PUT INTO OUR MOUTHS HAVE THINGS LIKE CHLOROPHYLL, FLAVONOIDS AND TERPENES AND THINGS LIKE THAT THAT ARE FROM TIME TO TIME CONSIDERED TO BE BIOACTIVE CONSTITUENTS. DIETARY SUPPLEMENT CONCENTRATED SOURCES OF THE BIO ACTIVES. IT'S NOT JUST THE NUTRIENTS. THERE'S BIOACTIVES AND AN ISSUE THAT IS EMERGING MORE AND MORE IS THE WHOLE ECOLOGY OF THE GUT, PROBIOT PROBIOTICS. MANY COMPOUNDS THE NUTRIENTS ACT AS SYMBIOTICS AND PREBIOTICS TO HAVE AN AFFECT ON THE NORMAL GUT FLORA AND WE SOMETIMES FORGET ABOUT THAT IN OUR RUSH TO OMICS AND HAVE TO TAKE INTO ACCOUNT THE ENTIRE COMPLEXITY OF THE ORGANISM. SO A COUPLE MORE QUESTIONS. A QUESTION ABOUT THE DOSE OF VITAMIN D OR YES OR NO ON THE VITAMIN D. THIS QUESTION CAME IN I BELIEVE DURING DR. O'BRIEN'S TALK SO I'LL ASSUME THE QUESTION IS ADDRESSED TO YOU, DR. O'BRIEN. DID YOU MEASURE THE DOSE OF VITAMIN D OR YES OR NO ON THE VITAMIN D. I GUESS WHAT THEY'RE TALKING ABOUT IS THE PERSONAL USE SUPPLEMENTS DURING THAT STUDY. >> OKAY. I CAN'T SEE THE QUESTION BUT YEAH, WE HAD SOME MEASURES. IT WASN'T A PERFECT MEASURE BUT WE TRIED TO GET PEOPLE TO LOOK AT THEIR SUPPLEMENT BOTTLE AND WRITE IT DOWN. WE DID HAVE SOME ESTIMATES FOR THAT. >> THAT WASN'T MUCH OF A QUESTION IT JUST SAID DID YOU MEASURE THE USE OF DOSE OR VITAMIN D OR YES OR NO. >> WE DIDN'T SEE A STRONG DOSE EFFECT. >> NEW. -- THANK YOU. THE QUESTIONS ARE STILL COMING IN SO I'M SWITCHING BACK AND FORTH FROM THE WORD DOCUMENT DR. KUSZAK PROVIDED. THANKS FOR A GREAT TALK, DR. YANG. ARE THERE PLANT SOURCES OF LCMUFA AND OTHERS FOR VEGETARIANS AND VEGANS? >> IT'S A WONDERFUL QUESTION. EVERYONE WANTS KNOW WHERE TO GET A DOSE OF DIETARY INGREDIENT. ONE TRICKY PART ABOUT LCMUFA AND MUFA IT'S A NAME FOR A BIG GROUP OF FATTY ACIDS. AOCMUFA HAVE ISOMERS AND THEY'RE ALSO IN MUSTARD OIL. SO WHEN WE SEARCH PEPPERS WE FOUND SOME VERY INTERESTING PAPER FROM INDIA SCIENTISTS THEY ALSO IN MUSTARD OIL AND FOUND SIMILAR RESULTS FROM THE OILS IN LIPID METABOLISM. SO FOR OMIC 11 LCMUFA IT'S MORE EXCLUSIVELY FOUND IN MARINE SOURCE FOR THE SMALL TYPE OCEAN FISHES. WHEN WE CHECKED MORE WE FOUND OUT IT'S BECAUSE WHAT IS FOUND IN THE OCEAN AND THEY CAN BE PURIFIED FROM ALGAE AND WE NEED MORE ANALYSIS OF THAT SOURCE. IN TERMS OF LONG CHAIN PUFA AND IT'S RESTRICTED BECAUSE IT'S RARE IN THE NATURAL SOURCE. FOR EXAMPLE, EVEN IN THE FISH WE CONCENTRATED PUFA FROM MARINE SOURCE. IT'S A REGIONAL CONCENTRATION IS LESS THAN 1%. YOU NEED TO MAKE A BIG EFFORT TO CONCENTRATION THEM HOWEVER, THERE'S ONE GROUP I DID NOT MENTION IS A LONG CHAIN FATTY ACID. IN GENERAL PEOPLE DO NOT THINK ANYTHING GOOD ABOUT SATURATED FATTY ACID. BUT FOR LONG CHAIN THIS FATTY ACID IS ENRICHED IN OUR SKIN FORM THE FILM. ALSO THERE'S A SOURCE THAT IS A LONG CHAIN FATTY ACID EXTRACTED FROM SUGAR CANE AND GRAINS AND IT SHOWED A CHOLESTEROL LOWERING AFFECT BUT THE STUDY CONTROVERSIAL AND MORE RESEARCH IS FOUND. -- NEEDED. >> THANK YOU, DR. YANG. I SENSE THE BIRTH OF A BRAND NEW INDUSTRY. >> BEFORE WE MOVE ON I WANTED TO COMMENT IT'S AN AL GO FATTY CHAIN OMEGA 3 THAT IS RECOMMENDED FOR VEGANS. >> I APPRECIATE THAT. A MILLION YEARS AGO AT FDA I REVIEWED A GRASS PETITION FOR DHA AND EPA. ONE WAS FOR A MARINE ALGAE SOURCE AND THE OTHER WAS FOR A FUNGAL CULTURE THAT WAS ENRICHED IN THE UNSATURATED FATTY ACID. THOSE HAVE BEEN AROUND SEVERAL DECADES NOW BUT THE ULTRA LONG CHAIN SOURCES THAT I THINK PEOPLE HAVEN'T BEEN PAYING AS MUCH AS ATTENTION TO BUT MAYBE AFTER TODAY THEY WILL. OKAY. I DID WANT TO ADDRESS A QUESTION THAT CAME IN EARLIER. ARE INDUSTRY SCIENTISTS ELIGIBLE TO APPLY FOR THE ODS SCHOLARS PROGRAM AND/OR FOR COLLABORATIONS WITH THE SCHOLARS? AND INDUSTRY SCIENTISTS ARE ELIGIBLE TO APPLY BECAUSE THESE ARE FUNDING PROVIDED BY ODS TO THE INTRAMURAL RESEARCH PROGRAM AT NIH. HOWEVER, THERE ARE OPPORTUNITIES FOR COLLABORATIONS THERE. INVESTIGATORS WHO ARE ODS SCHOLARS WHO WISH TO COLLABORATE WITH SOMEONE IN INDUSTRY FOR LET'S SAY MAKING MEASUREMENTS OF CONSTITUENTS OR INGREDIENTS OF WHATEVER THEY'RE STUDYING IN THE INTRAMURAL PROGRAM MAY HAVE AN OPPORTUNITY TO COLLABORATE OR INDUSTRY MIGHT POSSIBLY BE ABLE TO PROVIDE MATERIALS TO THE INVESTIGATOR AND THE INTRAMURAL PROGRAM FOR THE STUDY. TECHNICALLY YOU'RE NOT ELIGIBLE TO BE PART OF THE ODS SCHOLAR PROGRAM UNLESS YOU QUIT YOUR JOB AND BECOME AN INTRAMURAL PROGRAM AT NIH. THE COLLABORATION TO A LIM LIMITED EXTENT ARE POSSIBLE AND WAN TED TO GET THAT OUT OF THE WAY BEFORE WE WENT TOO MUCH FURTHER. HERE'S AN INTERESTING QUESTION I'LL DIRECT AT CARROLL -- CAROL HAGGANS. WHAT CAN ODS DO OR DID TO EDUCATE PEOPLE ABOUT DIETARY SUPPLEMENTS IN THE TIME OF COVID? >> I'LL START WITH THAT ONE. THAT'S TRUE. THERE'S ALWAYS BEEN A CERTAIN AMOUNT OF DISINFORMATION SURROUNDING DIETARY SUPPLEMENTS BUT IT TOOK OFF DURING THE PANDEMIC ALONG WITH SALES. WE SAW SALES INCREASE FOR IMMUNE SUPPORT AND VITAMIN D AND ZINC AND ELDER BERRY AND THINGS LIKE THAT. THE FDA HANDLES REGULATIONS FOR DIETARY SUPPLEMENTS AND FTC HANDLES ADVERTISING AND THEY CHOPPED ON MANUFACTURERS ILLEGALLY MARKETING THEIR PRODUCTS TO PREVENT OR TREAT DISEASE. OBVIOUSLY WITH COVID-19 DIETARY SUPPLEMENTS DO NOT PREVENT OR TREAT AND VACCINES ARE BEING DEVELOPED. THAT'S ONE OF THE REASONS WHY WE PUT TOGETHER OUR FACT SHEET ON DIETARY FACT SHEET ON SUPPLEMENTS FOR COVID-19 AND MANY PEOPLE WERE INTERESTED IN IMMUNE SUPPORT AND WANTED TO GET OUT INFORMATION AND THERE'S BEEN A COUPLE BIG TRIALS THE VITAMIN D TRIAL LOOKING AT ONE BOLUS DOSE OF VITAMIN C AND ZINC TRIAL. ANOTHER FOUND BENEFIT OF SUPPLEMENTATION BUT THE STUDIES OUT THERE ARE VERY SMALL, NOT RANDOMIZED BUT VERY PRELIMINARY RESEARCH BUT WE WANTED TO GET THAT OUT AND MAKE THAT AVAILABLE AND WE TRY TO KEEP IT UPDATED WHICH IS A FULL-TIME JOB. THAT'S ONE OF THE THINGS WE'RE TRYING TO MAKE THE INFORMATION AVAILABLE BECAUSE IT'S AN IMPORTANT QUESTION. THANK YOU. >> THANK YOU. AND THE CASE IS OFTEN A LACK OF EVIDENCE NOT EVIDENCE AGAINST DIETARY SUPPLEMENTS. THERE'S ALSO A FAIR AMOUNT OF ASSOCIATION OPPOSED TO CAUSALITY AND SPECULATION IN THAT PARTICULAR UNIVERSE. TRIALS WERE PEOPLE WERE MONITORING VITAMIN D LEVELS AND FINDING LOW LEVELS OF VITAMIN D AND THAT'S ASSOCIATION IS NOT NECESSARILY A CAUSALITY SO IT WILL TAKE A WHILE TO SORT OUT CAUSALITY VERSUS SIMPLE ASSOCIATION. THANK YOU, CAROL. ANYBODY ELSE HAVE ANYTHING TO ADD ON THAT TOP SNICK >> IT'S CERTAINLY TRUE I DON'T THINK ANY OF US BELIEVE THERE IS ANY DIETARY SUPPLEMENT AND A SUBSTITUTE FOR MASKI INING AND SOCIAL DISTANCING. >> IT'S INTERESTING. THERE WAS A FULL-COURT PRESS FROM NIH IN TERMS OF THE APPROACH TO THE SARS COV2 VIRUS WHEN IT FIRST STRUCK. NOT SIMPLY NUTRIENTS AND BOTANICALS AND THINGS LIKE THAT BUT I CITED ON A PRESENTATION BY PEOPLE IN A NATURAL DISCOVERY GROUP IN THE NATIONAL CANCER INSTITUTE AND THEY WERE SCREENING SOME OF THEIR OLD LEAD COMPOUNDS FROM VARIOUS MARINE AND TERRESTRIAL ORGANISMS AND THERE'S BEEN A HUGE EFFORT NOT NECESSARILY IN THE DIETARY SUPPLEMENT REALM BUT IN THE TREATMENT REALM AS WELL. SKY IT REALLY HAS BEEN ENORMOUS AND PUTTING TOO MUCH STOCK IN WISHFUL THINKING AND SPECULATION HAS HURT THE U.S. POPULATION. >> FREQUENTLY YOU HEAR THE QUESTION ABOUT WHAT ARE IMMUNE BOOSTING SUPPLEMENTS. THE BEST VITAMINS AND MINERALS AND SO ON BECAUSE PEOPLE ARE CONCERNED ABOUT TRANSMISSION OF INFECTIOUS DISEASES AND PARTICULARLY THE COVID DISEASE. WHAT ISN'T ALWAYS MADE AS CLEAR AS AN IT SHOULD BE IN THE MEDIA ALMOST ALL MICRONUTRIENTS HAVE A ROLE IN THE IMMUNE SYSTEM. SOME HAVE GREATER ROLES THAN OTHERS AND UNFORTUNATELY, OFTEN TIMES THAT IS A WORD GAME AND THE WORDS ARE MANIPULATED SO A VITAMIN AND MINERAL WITH A ROLE IN THE IMMUNE SYSTEM THEN BECOMES AN IMMUNE BOOSTING SUPPLEMENT YOU OUGHT TO TAKE AND A LEAP THAT SHOULDN'T BE MADE. SO LIKE YOU SAID, THERE'S A LOT OF STUDIES THAT DO SHOW THE ASSOCIATIONS BETWEEN GOOD HEALTH AND SUPPLEMENTS BUT NOT THE CAUSALITY. AND I WOULD JUST ADD TO THAT RECENTLY I THINK THERE'S BEEN A NUMBER OF VERY HELPFUL TALKS AND A RECENT WEBINAR WHERE DR. SHAW TALKED ABOUT MISINFORMATION AND DISINFORMATION AND WHAT THAT MEANS. IT'S A TOUGH PROBLEM. IT'S A TOUGH CHALLENGE TO GET THAT WORD OUT AND DISPERSED BUT WE'RE DOING OUR BEST AND THE UPDATE OF THE SUPPLEMENT FACT SHEET I THINK IS VERY HELPFUL. >> THANK YOU, DR. DEUSTER YOU HAD YOUR HAND UP? >> IT'S A SHAME WE HAVEN'T BEEN ABLE TO LOOK AT THE NUTRITION STATUS OF THOSE WHO HAVE GOTTEN COVID BECAUSE IT'S A POSSIBILITY THEY WERE LOW AND A LOT OF PEOPLE AREN'T GETTING WHAT THEY NEED SO THERE COULD BE NUTRIENTS THEY NEED JUST TO SUSTAIN THEIR SYSTEM. THERE'S A DIFFERENCE BETWEEN BOOSTING AND SUSTAINING BASED ON WHAT YOUR DIETARY INTAKE IS AND NUTRITIONAL STATUS IS. >> YEAH. THAT GETS INTO AN INTERESTING AREA WE TRIED TO ADDRESS TO SOME EXTENT FOR CERTAINLY SENTINEL NUTRIENTS AND THAT IS WE TALK ABOUT BIOMARKERS AND WE CAN TALK ABOUT BIOMARKERS OF DISEASE AND BIOMARKERS OF EXPOSURE AND STATUS. THE BIOMARKERS OF EXPOSURE CAN BE PRETTY FLEETING AS MENTIONED WHEN THE CASE WITH THE IODINE AND URINARY IODINES WHERE A BIOMARKER OF STATUS IS A VERY DIFFERENT THING AND MAY REQUIRE A DIFFERENT BATTERY OF TEST OR TEST ENTIRELY. SO PATTY, YOU BROUGHT UP A GOOD POINT WHEN WE TALKED ABOUT MONITORING NUTRITIONAL STATUS HOW MANY NUTRIENTS ARE THERE GOOD BIOMARKERS OF STATUS FOR. HOW MANY ANALYTICAL METHODS AND REFERENCE MATERIALS ARE NEED FORD THE BIOMARKERS OF STATUS VERSUS BIOMARKERS OF EXPOSURE. I JUST THROW THAT OUT TO THE CROWD AND ASK IF YOU'VE GOT SUGGESTIONS OR RECOMMENDATIONS, ANY OF YOU ON MY SCREEN NOW. OKAY. I'VE FLUMMOXED EVERYBODY. >> ZINC IS ONE WHERE WE'VE HAD SOME VERY INTERESTING WORK BY DR. JANET KING ON THE PROBLEM OF NOT HAVING GOOD BIOMARKERS IS A BIG ONE. >> I REMEMBER BACK WHEN I WAS RUNNING THE ANALYTICAL METHODS PROGRAM WE WITH TALKED ABOUT BIOMARKER OF STATUS FOR OMEGA 3s AND YOU CAN DO A SERUM MEASUREMENT IN A CIRCULATION AND IF YOU'VE JUST HAD A FISH SANDWICH YOUR OMEGA 3s WILL BE PRETTY HIGH DEPENDING ON WHAT KIND OF FISH IT WAS MADE OF AND DEPENDING LONG TERM THERE'S QUESTION ON RED BLOOD SELL MEMBRANES FOR OMEGA 3 CONTENT OR AN ADIPOSE BIOPSY STATUS FOR OMEGA 3s. THE SCIENTIFIC AND RESEARCH QUESTIONS AS WELL AS THE METHODOLOGICAL QUESTIONS NEED TO BE ADDRESSED AND APPROACHED. PERHAPS WE HAVE A NEW WORKSHOP TOPIC. WE HAVE A COMMENT. MANY THANKS FOR CELEBRATING THE 25th ANNIVERSARY. THE COMMENTER LEARNED MUCH. HE WAS DIRECTED TO NEW INFORMATION SOURCES INSPIRED BY THE PHYSICIAN SCIENTISTS AND REGISTERED DIETITIANS THAT ARE PART OF THIS AS WELL AS THE ODS STAFF. AND FINAL WISH TO STAY SAFE AND THANKS TO THE I.T. SUPPORT TEAM WHICH IS SOMETHING I DO HAVE TO SAY HAVE TAKEN ALL OF US AMATEUR I.T. PEOPLE AND MADE US INTO IT NOT PROFESSIONALS SEMI PROFESSIONALS AND I THINK WE'VE GOTTEN PRETTY GOOD AT THIS OVER THE LAST COUPLE DAYS. >> I HAVE ONE QUESTION. I THINK ALL OF US LOOKING AT YOU IN YOUR STUDY ARE WONDERING, FIRST IF THE PLANT IS GOING TO TAKE OVER THE ROOM AND SECONDLY, WE HOPE IT'S NOT CANNABIS SATIGO. >> ONE IS FICUS TREE. IF YOU WANT ME TO BORE YOU TO DEATH ABOUT MY ROMANTIC HABITS THE FICUS IS THE FIRST TREE ME AND WE WIFE BOUGHT 45 YEARS AGO AND 69 CENT AND FOUR INCHES HIGH AND BROUGHT IT AS KRESKY'S IF YOU CAN IMAGINE THE FIVE AN DIME AND KEPT IT 45 YEARS AND NOW IT'S EIGHT FEET TALL AND THE OTHER WAS SECOND WHEN WE MOVED FROM NEW YORK TO PHILADELPHIA AND THAT'S ALSO PROBABLY ABOUT 42, 43 YEARS OLD AND MY WIFE KEEPS SAYING WHY DO YOU KEEP THOSE UGLY THINGS AROUND AND I SAY DO NOT HAVE ANY ROMANCE IN YOUR SOUL. THAT'S PROBABLY TOO MUCH ABOUT ME. WE HAVE A QUESTION FOR DR. YANG. IS THERE ANYTHING ABOUT THE PUFA IN DIFFERENT SOURCES OF FOOD OR VEHICLES FOR ADMINISTRATION? I SENSE A COLLABORATION IN THE WORKS AND SOMEONE WANTS TO KNOW HOW STABLE THESE ARE IN ANIMAL CHOW. I'LL LET YOU ANSWER THE QUESTION. >> I THINK THE QUESTION IS FOR ME, YEAH. THE MORE IN FATTY ACID THE MORE UNSTABLE THEY ARE. OMEGA 3 AND DHE HAVE FATTY ACID WITHOUT DOUBLE BAND. IN GENERAL FISH OIL IS MORE UNSTABLE. IN TERMS OF LONG CHAIN MUFA MONOUNSATURATED FATTY ACID, IT'S RELATIVELY STABLE COMPARED TO PUFA OR MANY DOUBLE BANDS OF FATTY ACIDS. ACTUALLY IN OUR CLINICAL TRIAL, TO PERFORM A CLINICAL TRIAL IT'S EIGHT WEEKS ON EIGHT WEEKS OFF BUT THE PROCESS TAKES YEARS. IT'S LIKE FOR FOUR OR FIVE YEARS TO FINISH THE STUDY. WE CONTINUOUSLY DO THE CAPSULE AND AFTER THREE OR FOUR YEARS ON THE SHELF THERE'S STILL QUITE STABLE. AND THEY HAVE DOUBLE BANDS EXTREMELY UNSTABLE AND TO KEEP IT AT MINUS 80 FREEZER ALL THE TIME. WE COUPLE ASSUME DURING WHEN WE APPLY IT IT COULD BE AN ISSUE HOW TO KEEP IT STABLE OR DO CONTINUOUS QUALITY CONTROL AND PRODUCE SMALLER PORTIONS BASICALLY QUITE SIMILAR TO THE EPA AND DHA. >> THANK YOU VERY MUCH. IT'S ABOUT TIME TO THINK ABOUT WRAPPING IT UP. WE'RE STARTING TO LOSE PEOPLE. THERE ARE A COUPLE OF COMMENTS AND QUESTIONS THAT HAVE COME IN IN THE CHATEAU -- CHAT OPPOSED TO THE Q&A BOX. SHAME ON YOU. ONE FULL MEETING IS ALL AND THANK YOU FOR THE EXCELLENT 25th YEAR SESSION. THAT'S SIMPLY A COMMENT. SOMEONE INTERESTING IN THE QUININE TALK AND WE'LL LET SOMEBODY ADDRESS THAT ISSUE. AND AS A NEW STUDENT IN CLINICAL MASTER'S PROGRAM THIS HAS BEEN INFORMATIVE AND LOOK FORWARD TO MORE LEARNING OPPORTUNITIES. THANK YOU. THAT'S FROM A BRAND NEW STUDENT AND A QUESTION AND I'LL WRAP THIS UP AND IT'S A QUESTION FROM OUR PAST DIRECTOR. FASCINATING COUPLE OF DAYS FROM DR. COATES. WHAT DO YOU THINK THE FUTURE LOOKS LIKE FOR ODS? THEY WENT THROUGH AN EXCRUCIATING REVIEW OF FROM THE OFFICE OF THE DIRECTOR. IT TURNS OUT THE OFFICE OF DISEASE PREVENTION IS JUST CELEBRATING IT'S 35th ANNIVERSARY THIS YEAR. SO THEY WERE 10 YEARS OLDER AND PROMOTED OUT OF THAT OFFICE AND PUT DIRECTLY AS A SEPARATE AND INDEPENDENT OFFICE WITHIN THE DIVISION OF PROGRAM COORDINATION. I THINK WE HAVE A BRIGHT FUTURE AND AS A MORE INDEPENDENT OFFICE WE GAINED THINGS AND DON'T REALLY LOSE. WE GAIN THE ABILITY TO WORK INDEPENDENTLY WITHIN NIH AS PART OF AN ENTIRE DIVISION WHOSE JOB IS TO COORDINATE SUPPORT AND DEVELOP RESEARCH ACROSS TE BOARD IN VARIOUS FIELDS. OFFICE OF BEHAVIORAL RESEARCH AND SOCIAL SCIENCES OTHER OFFICES OFFICE OF RESEARCH PROGRAM AND DATA SCIENCE STRATEGY AND WE ARE IN THE PROCESS OF PLANNING A LARGE STRATEGIC PLAN I THINK I MENTIONED BRIEFLY YESTERDAY AND ONE THING IS WE'LL ADD A NEW GOAL AND ELEMENT TO OUR STRATEGIC PLAN TO COORDINATE RESEARCH ACROSS NIH AND DIETARY SUPPLEMENTS AND SHOULD EXPAND OUR GOAL. I WAS ASKED WHAT I THINK WITH THE FUTURE OF DIETARY SUPPLEMENTS AS A CATEGORY AND I SAID YOU NEED TO LOOK AT THE MARKET. IT'S A $55 BILLION INDUSTRY. THE UNITED STATES CONGRESS WHICH CREATED THE CATEGORY IS NOT GOING MAKE A $55 BILLION INDUSTRY GO AWAY. AS LONG AS THERE ARE DIETARY SUPPLEMENTS THERE'LL BE QUESTION THEM AND THE NEED FOR INDEPENDENT SCIENTIFIC ORGANIZATION LOOKS INTO THOSE QUESTIONS WILL REMAIN FOR AS LONG AS THE CATEGORY EXISTS. I THINK THE FUTURE IS BRIGHT. I'M NOT WEARING SHADES BUT I COULD BE. THANK YOU EVERYBODY. ON THAT NOTE I WILL WRAP UP. I WILL THANK THE I.T. TEAM ONCE AGAIN. YOU DID A FABULOUS JOB OF MAKING US LOOK GOOD. THANK YOU FOR THAT. I THANK THE ODS STAFF. IT'S BEEN KIND OF A FRAUGHT PROCESS AND WE PLANNING THIS OCTOBER OF 2020 AND THEN ALONG CAME THE PANDEMIC. THIS WAS SO IMPORTANT WE WANTED TO DO IT VIRTUALLY AND POSTPONED IT TO TOTAL OF JULY OF 2021 AND THIS WAS OUR END DATE WE EXPECT TO BE LIVE AND IN PERSON FOR THIS DATE AND HERE WE ARE. BE SAFE AND BE WELL AND BE INTERESTED AND INTERESTING AND THANK YOU EVERYBODY. I APPRECIATE EVERYTHING THAT YOU HAVE DONE. THE ATTENDEES HAVE BEEN TERRIFICALLY ATTENTIVE AND ASKED EXCELLENT QUESTIONS THANK YOU AND I'LL CLOSE WITH THOSE WORDS.