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n t summit on human performance and dietary supplements summary report maryelizabeth arensberg phd rd ld fada rebecca costello phd patricia a deuster phd mph facsm donnamariajones pharmd gwentwillman the ...

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    N
       T
            Summit on Human Performance and Dietary
            Supplements Summary Report
                   MaryElizabeth Arensberg, PhD, RD, LD, FADA
                   Rebecca Costello, PhD
                   Patricia A. Deuster, PhD, MPH, FACSM
                   DonnamariaJones, PharmD
                   GwenTwillman
              The use of dietary supplements to enhance human per-                                    he use of dietary supplements to enhance human
              formance among active individuals, athletes, the military,                   Tperformance among athletes, the military, and
              and other tactical populations is an increasingly popular                               other tactical populations is an increasingly pop-
              topic that often is not well understood. There are impor-                     ular topic that often is not well understood. To review the
              tant differences in nutrient needs between the general                        evidencebaseanddiscusskeyissues,theNationalStrength
              public and active adults. The United States has an established                andConditioning Association, National Institutes of Health
              regulatoryframeworkfordietarysupplements,andthesafety                         Office of Dietary Supplements, the American Society for
              and quality of dietary supplements can be strengthened                        Nutrition, and the EAS Academy hosted a Human Perfor-
              througheducation,third-partycertification programs, and                       mance and Dietary Supplements Summit August 9 to 10,
              increasedattentiontoseriousadverseeventreporting.This                         2012, in Bethesda, Maryland (Table 1).
              summary highlights these key issues, as well as research                      Morethan200professionals from the medical, nutrition,
              needs,areasforfutureconsideration,andothertopicsthat                          and athletic performance fields, as well as the military,
              werediscussedduringtheHumanPerformanceandDietary                              participated in the summit. This summary highlights the
              SupplementsSummit,heldAugust9to10,2012,inBethesda,                            key topics covered, research needs, future study consid-
              Maryland. Nutr Today. 2014;49(1):7Y15                                         erations,anddiscussionpointsaspresentedatthesummit,
                                                                                            without further elaboration.
            Mary Elizabeth Arensberg, PhD, RD, LD, FADA, is director, Health Policy         Phillips, MS,RD,CSSD,Athletes’PerformanceandCorePerformance;PaulM.
            andPrograms,AbbottNutrition Products Division of Abbott, Columbus, Ohio.        Coates,PhD,NationalInstitutesofHealth(NIH)OfficeofDietarySupplements;
            Rebecca Costello, PhD, is scientific consultant, National Institutes of         Ellen Coleman, MA, MPH, RD, CSSD, Academy of Nutrition and Dietetics
            Health (NIH) Office of Dietary Supplements, Bethesda, Maryland.                 Sports and Cardiovascular Nutrition Practice Group; R.C., (NIH) Office of
                                                                                            DietarySupplements;JohnE.Courtney,PhD,AmericanSocietyforNutrition;
            Patricia A. Deuster, PhD, MPH, FACSM, is professor and scientific di-           Kim Crawford, PhD, RD, CSSD, LDN, University of Pittsburgh; P.A.D., Uni-
            rector, Consortium for Health and Military Performance, Department of           formed Services University of the Health Sciences; Johanna T. Dwyer, DSc,
            Military and Emergency Medicine, Uniformed Services University of the           RD,NIHOfficeofDietarySupplements;DaveEllis,RD,CSCSCollegiateand
            Health Sciences, Bethesda, Maryland.                                            Professional Sports Dietitians Association; Daniel Fabricant, PhD, Food and
            Donnamaria Jones, PharmD, is deputy director, Uniformed Services Uni-           Drug Administration; Philip Gregory, PharmD, FACN, Natural Medicines
            versity Center Alliance for Dietary Supplement Research Department of           ComprehensiveDatabaseandCreightonUniversity;TravisHarvey,PhD,CSCS,
            Military and Emergency Medicine, Uniformed Services University of the           75th Ranger Regiment; Craig Horswil, PhD, University of Illinois Chicago,
            Health Sciences, Bethesda, Maryland.                                            DepartmentofKinesiologyandNutrition;RickKingston,PharmD,SafetyCall
                                                                                            International; Danny McMillian, PT, DSc, OCS, CSCS, University of Puget
            GwenTwillman, is managing director, Education and Professional De-              Sound; Stuart Meyers, OpTac International; CDR Rochelle Nolte, MD, US
            velopment, American Society for Nutrition, Bethesda, Maryland.                  Public Health Service; Rob Skinner, MS, RD, CSSD, Skinner Consulting;
            This article is a summary report of the 2-day Human Performance and             MarieSpano,MS,RD,LD,CSCS,CSSD,MarieSpanoNutritionConsulting;
            Dietary Supplements Summit held August 9 to 10, 2012, in Bethesda,              Keith Wheeler, PhD, FACSM, Abbott Nutrition; and Ed Wyszumiala, NSF
            Maryland.                                                                       International.
            SummitPlanningCommittee:M.E.A.,AbbottNutrition;R.C.,NIHOfficeof                 The authors currently are employed or consulting for the organizations
            Dietary Supplements; Cindy Davis, PhD, National Institutes of Health (NIH)      noted. The summit was developed and supported by the National Strength
            Office of Dietary Supplements; P.A.D., Uniformed Services University of the     and Conditioning Association, the National Institutes of Health’s Office of
            Health Sciences; Catherine Dratz, Abbott Nutrition; Steve Hertzler, PhD, RD,    Dietary Supplements, and the American Society for Nutrition; it was spon-
            AbbottNutrition;D.J.,UniformedServicesUniversity;VirginiaMeier,National         sored in part by the EAS Academy of Abbott Nutrition.
            Strength and Conditioning Association; Torrey Smith, National Strength and      Correspondence:MaryElizabethArensberg,PhD,RD,LD,FADA,HealthPolicy
            Conditioning Association; Anne Thurn, PhD, NIH; G.T., American Society          and Programs, Abbott Nutrition Products Division of Abbott, Department
            for Nutrition; and Keith Wheeler, PhD, FACSM, Abbott Nutrition.                 107740, 625 Cleveland Ave, Columbus, OH 43215 (mary.arensberg@
            Summit Faculty: Pamela A. Anderson, PhD, RD, Abbott Nutrition;                  abbott.com).
            Carmen Caraballo, MS, RD, US Military Academy; Amanda Carlson-                  DOI: 10.1097/NT.0000000000000013
                                                                                                                                                            \
            Volume 49, Number 1, January/February 2014                                                                                 Nutrition Today                7
                  Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
          TABLE 1 Objectives of the Summit on                                1994 Dietary Supplement Health and
                       HumanPerformanceandDietary                            Education Act
                       Supplements                                           Thefirstamendmentisthe1994DietarySupplementHealth
                                                                             and Education Act, which provides the overall regulatory
          & Define the nutrition needs of active adults and athletes         framework for dietary supplements to help ensure safety
          & Discuss dietary supplement use in active adults, elite           by establishing specific labeling and notification require-
           athletes, and tactical populations                                ments, authorizing the FDA to develop rules for good
                                                                             manufacturing practices, and giving the FDA authority to
          & Examinetheimpactofdietarysupplementsonperformance,               removeadietary supplement from the market if the FDA
           competition, and training                                                                          1
                                                                             finds the product is ‘‘unsafe.’’
          & Discuss the translation and application of the available
           evidence for educating appropriate audiences                      2006 Dietary Supplement and Nonprescription
          & Review certification, testing, safety issues, and adverse events DrugConsumerProtection Act
          & Identify research gaps and opportunities for further research    This second amendment requires companies that manufac-
                                                                             ture or distribute dietary supplements to report information
                                                                                                                           2
                                                                             about serious adverse events to the FDA.
         Afewdecades ago, sports nutrition science was in its in-            Labeling requirements for dietary supplements are simi-
         fancy. Athletes and fitness enthusiasts struggled for ways          lar to those of conventional foods. Both must have the
         tobestdefinetheirnutritionneedsandbalancethemwith                   following:
         the demands of rigorous training and busy lifestyles. Today,        & statements of identity/descriptive names; in addi-
         science-basedsolutions are available in the form of sports             tion, a dietary supplement also must state that it is a
         dietary supplements, conventional foods, and functional                ‘‘supplement’’;
         foods,developedspecificallyassportsnutritionproducts.               & nameandplace of business of the company manufactur-
         These products can provide a framework for good nutri-                 ing, packing, and distributing the product;
         tion and can offer quality, balanced nutrition, and con-            & nutrition labeling panelVthe Nutrition Facts panel for
         venience. The key to understanding the differences in                  conventional foods and Supplement Facts panel for
         these types of products is to consider the form, composi-              dietary supplements;
         tion, labeling, and use of each.                                    & complete ingredient listing (Table 2), net contents of
                                                                                the product, and serving size;
         DIETARYSUPPLEMENTREGULATIONS                                        & dietarysupplementsalsomustlistanaddressandphone
         IN THEUNITEDSTATES                                                     numberforserious adverse event reporting.
         Thesummithighlightedthedietarysupplementregulatory                  Advertisements and labels for dietary supplements can-
         framework in the United States. Like all foods, dietary             not make disease claims, such as stating the product will
         supplements and conventional foods marketed for sports              help prevent, treat, cure, or mitigate an illness/disease.
         nutrition are regulated by the US Food and Drug Admin-              However, dietary supplements, like conventional foods,
         istration (FDA). Federal law defines dietary supplements            can make health claims. Health claims describe a relation-
         as products taken by mouth that contain a ‘‘dietary ingre-          ship between a substance and a disease or the reduc-
         dient’’ and are intended to ‘‘supplement’’ the diet:                tion of risk for a disease. The FDA must preapprove the
         & The ingredients in dietary supplements may include vi-            health claims, and the product’s label must contain a
           tamins, minerals, herbs, or other botanicals, amino acids,        disclaimer specifying that the statements were not eval-
           enzymes, organ tissues, glandulars, concentrates, me-             uated by the FDA. Both dietary supplements and con-
           tabolites, constituents, and/or extracts.                         ventional foods also can make nutrient content claims
         & Dietary supplements are available in tablet, capsule,             that are preapproved by the FDA (eg, sugar free, low fat,
           liquid, powder, soft gel, or gel cap form.                        or low sodium).
         & Manufacturers cannot promote these products as con-               Dietary supplements and conventional foods can make
           ventionalfoodsorforuseastheonlyitemofamealordiet.                 structure/function claims (eg, calcium builds strong bones,
                                                                             or fiber maintains bowel regularity). However, manufac-
         The Federal Trade Commission prohibits using unfair or              turers of dietary supplements must provide notification to
         deceptive practices to sell any dietary supplement or con-          FDAofthese claims (no later than 30 days after marketing
         ventional food. Dietary supplements also must meet the              a product with a structure/function claim) and add a dis-
         requirements of 2 amendments of the US Food, Drug, and              claimer on the product’s label that the statements were not
         Cosmetic Act that are specific to dietary supplements.              evaluatedbytheFDA.Inaddition,structure/functionclaims
         8       Nutrition Today\                                                                        Volume 49, Number 1, January/February 2014
                Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
           TABLE 2 Regulations for Ingredients in                            understand how nutrient needs are estimated and the po-
                        Conventional Foods and Dietary                       tential impact of performance activities. Dietary Reference
                                                                                            3
                        Supplements                                          Intakes(DRIs) arecalculatedusing‘‘referencepeople’’of
                                                                             specific height, weight, sex, physical activity, and environ-
           Ingredient safety                                                 mental conditions. However, many active people do not
             Manufacturers are responsible for ensuring the safety of        fit into these standard reference categories. The Military
                                                                                  4
             their products; the regulations governing safety of             DRIs were derived from the DRIs to meet the increased
             ingredients used in conventional foods vs dietary               activity levels and greater environmental stresses faced by
             supplements differ in several ways.                             military populations and are used to develop menu stan-
           Ingredients added to conventional foods must meet one of          dards for the military.
           these requirements:                                               Some special populations, such as individuals who are
                                                                             veryfitandactiveand/orareperformingatenvironmental
             & Havebeeningeneraluseinfoodspriorto1958(whenthe                extremes (eg, combat personnel, first responders, and
               Food Additives Amendment to the Federal Food, Drug,           professional athletes), may require adjustments in their
               and Cosmetic Act was enacted)                                 DRIs. Whereas recommendations for vitamins and min-
              & ComplywithaUSFoodandDrugAdministration(FDA)Yissued
               food additive regulation (specifies amount and purpose of     erals remain fairly constant for active versus inactive in-
               ingredient)                                                   dividuals,needsforwater,electrolytes,energy,and,under
             & Be generally recognized as safe (GRAS) by qualified experts,  certain circumstances, macronutrients (carbohydrate, pro-
               meaningsafeuseoftheingredienthasbeendevelopedunder            tein, and fat) may differ.
               scientific procedures or through commonuseinfood,sothere      Theestimated energy requirement is the average dietary
               is ‘‘general recognition of safety’’ among qualified experts
               (FDA premarket notification of GRAS ingredients is            energy intake needed to maintain energy balance in a
               voluntaryVlisting available at http://www.accessdata          healthy adult of defined age (in years), sex, height (in
               .fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing)       meters),weight(inkilograms),andphysicalactivitylevel
                                                                             (PAL).3ThePALfactorsarebasedontheactivitylevelsof
           Ingredients used in dietary supplements must meet one of          the general population (Table 3), which are possibly too
           these requirements:
                                                                             low for very active people.
             & Have been in general use prior to October 15, 1994            For example, a competitive or tactical athlete could ex-
               (when the Dietary Supplement Health and Education Act         pendupto6000kcal/d,whichmayrequireaPALof3or
               was implemented)                                              more. The estimated energy requirement equations for
             & Be in compliance with the notification for a new dietary
               ingredient (NDI), which requires a 75-d premarket             adults are as follows:
               notification to FDA, unless the NDI and any other ingredients
               in the dietary supplement have been present in the food               Adult Men EER ¼½662ðÞ9:53age þPA
               supply and used for food                                                   ½ðÞ15:91  weight þðÞ539:6  height
              & For more information about the safety of dietary ingredients,
               visit http://www.fda.gov/Food/DietarySupplements/Alerts/            Adult Women EER ¼½354ðÞ6:91age þPA
               default.htm and http://ods.od.nih.gov/factsheets/list-all/                  ½ðÞ9:36  weight þðÞ726  height
             Abbreviation: NDI, new dietary ingredient.                      where PA is the physical activity coefficient derived from
                                                                             the PAL (Table 3). Acceptable macronutrient distribution
          arerequiredtohavesubstantiation,supportedbycompetent               ranges for carbohydrate, protein, and fat are 45% to 65%,
          and reliable scientific evidence.                                  10%to35%,and20%to35%oftotalcalories,respectively.
          Four principal issues guide whether a claim is substantiated:      However,different ranges are recommended to meet the
                                                                             carbohydrateandproteinneedsofveryactiveindividuals.
          & meaning of the claim being made,                                 TheRecommendedDietaryAllowanceforprotein,which
          & relationship of the evidence to the claim,                       covers requirements for nearly all healthy, nonathletic
          & quality of the evidence, and                                     adults, is set at 0.8 g/kg per day. Yet, protein intake rec-
          & totality of the evidence.                                        ommendationsinthe sports nutrition literature vary from
                                                                             1.2 to 2.0 g/kg per day, based on body composition, type
                                                                                                             5
          DIFFERENCESBETWEENNUTRIENT                                         of exercise, and health status.
          NEEDSOFTHEGENERALPUBLICAND                                         Although the DRIs provide an evidence base from which
          ACTIVEADULTS                                                       to derive nutrient recommendations, they are incomplete
                                                                             for athletes and others engaged in strenuous activity. Op-
          Another area addressed at the summit was nutrient needs            timal intakes before, after, and during exercise and spec-
          and human performance. When considering the use of di-             ificity for individuals of varying body composition are not
          etary supplements for human performance, it is helpful to          addressed by the DRIs. Recommendations are available
                                                                                                                                   \
          Volume 49, Number 1, January/February 2014                                                             Nutrition Today          9
                Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
         TABLE 3 Physical Activity Coefficients (PA values) for Use in Estimated Energy
                      Requirement Equations
                                                 LowActive                                         Very Active (PAL 1.9Y2.5)
                                               (PAL: 1.4Y1.59)              Active              Typical Daily Living Activities,
                                                Typical Daily          (PAL 1.6Y1.89)           Plus at Least 60 min of Daily
                            Sedentary         Living Activities,    Typical Daily Living          Moderate Activity, Plus an
                         (PAL 1.0Y1.39)      Plus 30Y60 min of         Activities, Plus        Additional 60 min of Vigorous
                          Typical Daily       Daily Moderate           60 min of Daily              Activity or 120 min of
                        Living Activities          Activity          Moderate Activity                 Moderate Activity
         MenQ19y                1.00                 1.11                     1.25                             1.48
         WomenQ19y              1.00                 1.12                     1.27                             1.45
           Abbreviation: PAL, physical activity level.
        from other sources, such as the American Academy of Nu-          evolve according to their individual goals, using an ap-
        trition and Dietetics, the Dietitians of Canada, the American    proach such as this multistep process:
        College of Sports Medicine, and many professional journals       & Step 1: Provide comprehensive education, helping ath-
        and publications.                                                   letesseehownutritionalstrategiescanhelpthemachieve
        DIETARYSUPPLEMENTUSEINACTIVE                                        their goals
        ADULTS,ATHLETES,ANDTACTICAL                                      & Step 2: Offer clear and concise materials to promote
        POPULATIONS                                                         understanding of dietary supplement use
                                                                         & Step3:Provideguidanceonhowtoconfiguresolutions
        Thesummitexploredthe uses of dietary supplements by                 specific to their goals
        different population groups. There is some research on the       & Step4:Givefollow-upguidanceonhowtoexecutetheir
        efficacy of various dietary supplements and their impact on         plans.
        both health and human performance, but it is limited. The        Professional and Collegiate Athletes
        role of dietary supplements in human performance is to
        supportthephysiologicalneedsofametabolicsystemunder              Formanyathletes,overreaching+overtraining=performance
        stress and to complement the body’s effort to mobilize fuel,     incompetence.Forprofessional athletes, a long in-season
        maintain focus, or accelerate recovery. Several dietary sup-     grind and short off-season restorative period increase the
        plements are shown to complement training and human              potential for underrecovery and deconditioning. Sports
                                                        3,6              dietitians often see professional athletes suffering from
        performance,andothersstillareunderstudy.           Clear and
        concise information on dietary supplement strategies that        chronicfatiguebecauseofunderresting,stimulantoveruse,
        can benefit active populations and influence goal achieve-       drug use, and binge alcohol use similar to what occurs in
        ment is needed, but reinforcing the role of conventional         the general population. In addition, some athletes may have
        foods also is important. Following are considerations for        off-season binge-eating patterns that can result in chronic
        several specific populations.                                    dehydration, poor sleep, anxiety, and vulnerability to ex-
                                                                         ertion and environmental stressors.
                                                                         The National Collegiate Athletic Association (NCAA) has
        The nutrition needs of very active                               establishedspecific sports nutrition rules that govern how
        adults require more study.                                       teamscanfeedtheirplayers(eg,specifyinginstitutionsmay
                                                                         provide only 1 training table meal per day to a student
                                                                         athlete, but that institutions may provide fruit, nuts, and
                                                                         bagels at any time).
        Active Adults and Athletes                                       The NCAA also has rules that allow student athletes to
        Active adults and athletes often view dietary supplements        receivenutritionalsupplementsforadditionalcaloriesand
        asawaytoimprovetheirperformance,helpthemachieve                  electrolytes. Permissible nutritional supplements cannot
        a goal faster, and maintain their health. Most active adults     contain any NCAA-banned substances and are identified
        and athletes do not question whether the dietary supple-         accordingtoclassesVcarbohydrate/electrolytedrinks,energy
        ments that they take actually are improving their perfor-        bars, carbohydrate boosters, and vitamins and minerals.
        mance. They may take a product simply because of the             The NCAA recently adopted a policy that schools must
        label ‘‘promises.’’ Sports dietitians can help active adults     designate an individual as the athletic department’s re-
        and athletes develop nutritional strategies and plans that       source for questions related to nutritional supplements,
        10       Nutrition Today\                                                                  Volume 49, Number 1, January/February 2014
               Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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...N t summit on human performance and dietary supplements summary report maryelizabeth arensberg phd rd ld fada rebecca costello patricia a deuster mph facsm donnamariajones pharmd gwentwillman the use of to enhance per he formance among active individuals athletes military tperformance other tactical populations is an increasingly popular pop topic that often not well understood there are impor ular review tant differences in nutrient needs between general evidencebaseanddiscusskeyissues thenationalstrength public adults united states has established andconditioning association national institutes health regulatoryframeworkfordietarysupplements andthesafety office american society for quality can be strengthened nutrition eas academy hosted perfor througheducation third partycertification programs mance august increasedattentiontoseriousadverseeventreporting this bethesda maryland table highlights these key issues as research morethanprofessionals from medical areasforfutureconsideratio...

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