Nutritional Supplement Research: Beyond the Status Quo

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Nutritional Supplement Research: Beyond the Status Quo. Overview. Background What is the Status Quo? Common Problems and Solutions Quality control Dosing. Background. Dietary Supplement Health and Education Act of 1994 (DSHEA) DSHEA deregulation No GMPs No quality control standards - PowerPoint PPT Presentation

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Slide 1Nutritional Supplement Research: Beyond the Status QuoBackgroundWhat is the Status Quo?Common Problems and SolutionsQuality controlDosingOverviewBackgroundDietary Supplement Health and Education Act of 1994 (DSHEA)DSHEA deregulationNo GMPs No quality control standardsNo requirement to show safety or efficacyThe Office of Dietary Supplements (ODS) was established through DSHEA (by NIH in 1995) and collaborates with the National Center for CAM (NCCAM)ODS and NCCAM promote and award funding for scientific research on dietary supplementsNesheim, Pub Health Nutr, 1999www.ods.od.nih.govTable 1. Total number of projects and funding for the NIH and USDA top 10 dietary supplement ingredients in the CARDS database, FY 1999-2007NIHUSDAIngredientProjects, nFunding, USD millionsProjects, nFunding, USD millionsVitamins and minerals319710931443294Botanicals158343959287Phytochemicals1470415697123Fatty acids and lipids1051304685130Proteins and amino acids59715622945Antioxidants52814229082Dietary Fiber and carbohydrates1967916524Hormones/precursors18557101Other19663649BackgroundRegan et al., J Nutr, 2010$1.9 billion$347 millionNCCAM$370 millionMitochondriaMitochondrialenzymesIATask Area IYear 1 12 months> 20% changeTo Task IITask Area IIIYear 2 18-24 monthsIIIAIIIBIIICIIIDIIIEEndurance PerformanceSoldier Task PerformanceMuscle InjuryInflammationCognitive PerformanceEnvironmental ExtremesPerformanceTo Task IVEach > 20% change: IIIA or IIIB or IIIC or IIID or IIIEHuman Performance TestingTask Area IVField Testing PerformanceFinal FormulationIncorporation into RationTransition to RationTask Area IIYear 112 monthsIIAIIBIICIIDBioavailability DosingHumanPharmacokineticsAcceptableFormulationAcceptableTo Task IIIAchievedCompletedHedonics > 6Analysis FRS ComponentsMitochondriaMitochondrialenzymesIATask Area I> 20% changeTo Task IIMitochondriaMitochondrialenzymesIAMitochondriaMitochondrialenzymesIATask Area I12> 20% changeTo Task IITask Area IIIYear 2 18-24 monthsIIIAIIIBIIICIIIDIIIEEndurance PerformanceSoldier Task PerformanceMuscle InjuryInflammationCognitive PerformanceEnvironmental ExtremesPerformanceTo Task IVEach > 20% change: IIIA or IIIB or IIIC or IIID or IIIEHuman Performance TestingTask Area IIIYear 2 18-24 monthsIIIAIIIBIIICIIIDIIIEEndurance PerformanceSoldier Task PerformanceMuscle InjuryInflammationCognitive PerformanceEnvironmental ExtremesPerformanceTo Task IVEach > 20% change: IIIA or IIIB or IIIC or IIID or IIIETask Area IIIYear 2 18-24 monthsIIIAIIIBIIICIIIDIIIEEndurance PerformanceSoldier Task PerformanceMuscle InjuryInflammationCognitive PerformanceEnvironmental ExtremesPerformanceTo Task IVEach > 20% change: IIIA or IIIB or IIIC or IIID or IIIEHuman TestingTask Area IVField Testing PerformanceFinal FormulationIncorporation into RationTransition to RationTask Area IVField Testing PerformanceFinal FormulationIncorporation into RationTransition to RationTask Area IIYear 112 monthsIIAIIBIICIIDBioavailability DosingHumanPharmacokineticsAcceptableFormulationAcceptableTo Task IIIAchievedCompletedHedonics > 6Analysis FRS ComponentsTask Area IIYear 112 monthsIIAIIBIICIIDBioavailability DosingHumanPharmacokineticsAcceptableFormulationAcceptableTo Task IIIAchievedCompletedHedonics > 6Task Area IIYear 112 monthsIIAIIBIICIIDBioavailability DosingHumanPharmacokineticsAcceptableFormulationAcceptableTo Task IIIAchievedCompletedHedonics > 6Analysis FRS ComponentsWhat is the Status Quo?Slide provided courtesy of Dr. Ed Zambraski, USARIEMIdeal?What is the Status Quo?Source of Supplement?:Usually off-the-shelfVerification of quality?:Usually notDose?:Usually what others have usedKinetics/bioavailability?:Usually notStudy design?:Usually good!Data analysis?:Conventional and soundData display & interpretation?:Usually marginal or poorReality?Quality Control(Problem - Dissolution)> 50% of calcium supplements and many single and multivitamin-mineral preparations fail to meet USP disintegration and dissolution standards. > 40% of melatonin supplements fail to meet USP disintegration standards.Carr and Shangraw, Am Pharm, 1987 (adapted from Table 3)Carr and Shangraw, Am Pharm, 1987; Shangraw, Pub Health Rep Suppl, 1990;Hahm et al., J Am Pharm Assoc, 1999Quality Control(Problem - Content)Gurley et al., Am J Health Syst Pharm, 2000Harkey et al., Am J Clin Nutr, 2001Parasrampuria et al., JAMA 1998Green et al., Clin J Sports Med, 2001Andrews et al., Anal Bioanal Chem, 2007Pharmaceutical Standard (USP)Good Manufacturing Practices (GMP) provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity that it claims. Three independent non-governmental programs provide GMP guidelines for dietary supplements. Adoption is VOLUNTARYNatural ProductsAssociation (NPA GMP)NSF GMPUSP Dietary Supplement Verification ProgramQuality Control(Solution)Quality ControlA word about mixtures (cocktails) or Product TestingEffects (or lack of effects) observed using multiple ingredients violates basic scientific philosophy.There is no way to know if the ingredients (or which ingredients) are acting synergistically, antagonistically, or if they are biologically active at all. > 100 interactions possible between ingredient pairs; > than 1,000,000 interactions possible among random groupings SuperStuff50005x stronger than our 1000 formula!Ingredient List:Chinese Ginseng, SiberianGinseng, Vitamin B-12, Guarana,Yohimbine, L-Carnitine, Bee Pollen, Caffeine, Ginkgo Biloba (leaf), Coenzyme Q10, DHEA, SAMe, Fish Oil, Quercetin, Glucosamine Chondroitin, FD&C Green #2 .Product Claims: Boost Immunity Reverse Male-Pattern Baldness Burn Fat Improve Memory Increase Energy Enhance Labido

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