Is the RDA! the Appropriate Marker of Adequacy?!
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1 International Alliance of Dietary/Food Supplement Associations The 4 th IADSA International Scientific Forum Buenos Aires 1-2 September 2011 Achieving Micronutrient Adequacy and Minimising Risk of Overconsumption: The Role of Food Supplements! Is the RDA! the Appropriate Marker of Adequacy?! Jeffrey Blumberg, PhD, FACN, FASN, CNS! Friedman School of Nutrition Science and Policy! Jean Mayer USDA Human Nutrition Research Center on Aging! Tufts University! Boston, MA USA! Adequacy of Nutrient Intake: Adequate for What - Health?! Health is a state of complete physical,! mental and social well-being and! not merely the absence of disease or infirmity.! Preamble to the Constitution of the WHO! (adopted by the International Health Conference! New York, June, 1946)! 1!
2 Frequency Distribution of Individual Requirements! No Standardized Terminology or Framework for Recommended Micronutrient Intakes! Recommendation! USA! Canada! Umbrella! DRI! DRV! UK! EC! Mexico! WHO! FAO! Average! EAR! EAR! AR! RN! Recommended! RDA! RNI! PRI! IDR! RNI! Lower! LRNI! LTI! Safe! AI! IDS! Upper! UL! LSC! UL! 2!
3 Dose-Response Curves Used to Establish Dietary Reference Values! Open boxes, evidence-based data; Shaded box, derived data! Fairweather-Tait. Am J Clin Nutr 2011! Suggested Harmonized Terminology! Umbrella! Recommendation! Average Requirement! Harmonized Term! Nutrient Intake Value, NIV! Average Nutrient Requirement, ANR! Recommended Intake Level! Individual Nutrient Level, INL x! (x = percentile chosen)! Upper Level of Safe Intake! Upper Nutrient Level, UNL! King et al. Food Nutr Bull 2007! 3!
4 Estimating ANR and INL x from a Symmetrical Distribution of Requirements! King et al. Food Nutr Bull 2007! RDA Definitions of Adequacy! Recommended Dietary Allowance (RDA)! Judged to be adequate to meet the known nutrient! needs of practically all healthy people! Estimated Average Requirement (EAR)! Mean daily nutrient intake that meets the requirement! of half the healthy individuals in particular age- and! sex-specific groups! Adequate Intake (AI)! Intake by a defined population group that appears! to sustain health! 4!
5 NAS/IOM Dietary Reference Intakes! Model for Impact of Different Criteria Used to Establish Adequacy! Because nutrients have multiple sites of action in human! metabolism, it is possible to demonstrate abnormal function! in one parameter measured or observed as a result of inadequate! intake of a nutrient, while other parameters requiring the same! nutrient appear normal or within normal ranges.! Yates Food Nutr Bull 2007! 5!
6 Criteria for Nutrient Adequacy! Nutrient thresholds are different for different outcomes:!! Vitamin C!!scurvy < urinary excretion < antioxidant!! Vitamin D!!rickets < osteoporosis < colorectal cancer!! Vitamin E!!myopathy < immune function < venous thromboembolism!! Folic acid!!megaloblastic anemia < neural tube birth defects! Top Ten Causes of Death: 1900 and 2000! Rank! 1900! 2000! 1! Pneumonia! Heart Disease! 2! Tuberculosis! Cancer! 3! Diarrhea, enteritis! Stroke! 4! Heart disease! Emphysema, chronic bronchitis! 5! Liver disease! Unintentional injuries! 6! Injuries! Diabetes! 7! Stroke! Pneumonia, influenza! 8! Cancer! Alzheimerʼs disease! 9! Senility! Kidney failure! 10! Diphtheria! Septicemia! US DHHS 2000; Natl Ctr Hlth Statistics 2001! 6!
7 Selecting Health Outcomes for Establishing Nutrient Reference Values! Reduction in risk of chronic disease is a concept! that should be included in the formulation of future RDAs where sufficient data for efficacy and safety exist. (IOM, 1994)! Moving beyond nutrient essentiality (prevention of deficiency syndromes) to long-term outcomes: Selection of appropriate endpoints are challenging because of a lack of precise associations between dietary intakes, nutrient status, and chronic disease.! Pathophysiology of chronic diseases are multifactorial (including genetics, lifestyle, environmental exposure) and not single nutrientspecific.! Classes of Nutritional Biomarkers! Raiten et al. Am J Clin Nutr 2011! 7!
8 Research Approaches and Possible Outcome Measures for Nutrient Adequacy! Observational - Nutrient status! Plasma vitamin K in healthy populations! Factorial Estimation or Nutrient Balance! Equilibrium maintenance of iron! Depletion/Repletion - Metabolic! Urinary excretion of 4-pyridoxic acid from vitamin B6! Bioactivity - Biochemical! Antioxidant actions of vitamin C in leukocytes! Clinical Evaluation - Functional! Vitamin A modulation of dark adaptation! Chronic disease (Randomized Clinical Trial)! Calcium-associated osteoporosis/fracture rate! Estimated Average Requirement! 8!
9 Prevalence of Nutrient Inadequacy! Murphy and Vorster. Food Nutr Bull 2007! Biomarkers of Vitamin A Status Continuum! Proposed in 2001! Proposed in 2010! Tanumihardjo. Am J Clin Nutr 2011! 9!
10 Vitamin D and Mineralization of Bone! Osteoid Volume! Ratio of unmineralized/total bone mass! IOM! Recommendation! Priemel et al. J Bone Min Res 2010! Vitamin D Intakes Recommended by IOM and Endocrine Society Practice Guidelines Committee! Holick et al. J Clin Endocrinol Metab 2011! 10!
11 Generic Analytic Framework for Determining Nutrient References! Russell et al. Agency Healthcare Res Qual 2009! Analytic Framework for Calcium and/or Vitamin D! 11!
12 Evidence-Based Medicine: Grades of Evidence Hierarchy of Research Designs for Efficacy! I.!Properly randomized, controlled trial! II.1!Well-designed controlled trial without randomization! II.2!Well-designed cohort or case-control analytic study! II.3!Multiple time series with or without intervention! III.!Opinions of respected authorities; descriptive studies or case reports; reports of expert committees! US Preventive Services Task Force 1996! Other Issues Impacting Considerations of Nutrient Adequacy! Nutrient-nutrient and network interrelationships! Imperative of the demographics of aging! Growing prevalence of overweight and obesity! Emerging methodologies! 12!
13 Dynamic and Synergistic Interactions in the Antioxidant Defense Network! Yeum et al. Arch Biochem Biophys 2004! Antioxidants Slow Progression to Age-Related Macular Degeneration Age-Related Eye Disease Study RCT! n=4757! age=65-80 y! vitamin C, 500 mg! vitamin E, 400 IU! β-carotene, 15 mg! zinc, 80 mg! copper, 2 mg! Probability of Advanced AMD! Visual Acuity Loss! AREDS Research Group. Arch Ophthalmol 2001! 13!
14 Antioxidant Supplementation Improves Adultsʼ Cognitive Performance SU.VI.MAX Trial! Scores after antioxidant supplementation were higher than! after placebo for episodic memory (P=0.04), verbal memory! in non-smokers and low vitamin C status (P=0.05), and! executive function in low vitamin E status (P=0.02)! RCT! n=4447! age=45-60 y! vitamin C, 120 mg! vitamin E, 30 mg! β-carotene, 6 mg! selenium, 0.1 mg! zinc, 20 mg! Kesse-Guyot et al. Am J Clin Nutr 2011! Co-dependence of Calcium and Vitamin D for Calcium Bioavailability! In the absence of Ca,! vitamin D will not result! in sufficient absorption! ACTIVE ABSORPTION (%) In the absence of! vitamin D, not enough! Ca absorbed! 14!
15 Interactions between B Vitamins in Homocysteine Metabolism! Co-dependence of Folic Acid and Vitamin B12 for Reduction of Stroke and Coronary Events Vitamin Intervention for Stroke Prevention! B12 < or > median 322 pmol/l! Hi, >B12! Cumulative Proportion! Lo, >B12! Lo, <B12! Hi, <B12! Hi v. Lo Dose! B12, 400 v. 6 µg! B6, 25 v. 0.2 mg! FA, 2.5 v mg! Spence et al. Stroke 2005! Follow-up (d)! RCT, n=2155, 66 y, hx stroke! 15!
16 Content of Most Commonly Used Multivitamin Danish National Birth Cohort! Catov et al. Am J Clin Nutr 2011! Periconceptual Multivitamin Use is Associated with Lower Risk of Preterm and Small-for-Gestational Age Births Danish National Birth Cohort! Preterm Rate!!! Small-for-Gestational Age! HR: 0.84 (0.72, 0.97)!! HR: 0.83 (0.73, 0.95)! Catov et al. Am J Clin Nutr 2011! Prospective Cohort! n=35,897! Users=21,785 (60.7%)! 16!
17 Micronutrient Adequacy with the Challenge of an Aging Population! Age-Related Changes in RDAs! Age! Ca! Cr! Fe! Na! Cl! vd! vb6! 31-50! -! -! -! -! -! -! -! 51-70! -!!!!! -!! >70!! --! --!!!! --! 17!
18 Adequacy for Healthy People with Increasing Prevalence of Drug Use! Percentage of Persons Using Rx Drugs! Percentage of Rx Drugs in Past Month! NCHS/CDC. Data Brief 2010! RCTs of Nutrients in Secondary Prevention Heart Outcomes Prevention Evaluation! Percent of Subjects Receiving Drugs in the Vitamin E Group! Drugs! HOPE! HOPE 2! β-blockers! 39.9! 40.2! Antiplatelet agents! 77.0! 76.7! Lipid lowering agents! 28.4! 28.3! Diuretics! 15.7! 15.2! Calcium channel blockers! 47.2! 46.7! Lonn et al. JAMA 2005! 18!
19 Micronutrient Adequacy with the Challenge of Global Obesity! WHO. 2005! Reference Weights and Heights Used in Deriving Nutrient Intake Values! D-A-CH (Germany, Austria, Switzerland, Slovenia) based on FAO/WHO/UNU 1985 report! Finnish (1999) and French (2001) adopted reference weight of 70 kg for men and 60 kg for women! Mexico based on FAO/WHO/UNU report with BMI of 21 in men and 22 in women! 19!
20 Reference Weights and Heights Used in Deriving Nutrient Intake Values! US/Canada based on BMI collected from NHANES III between : Reference weights of adults aged applied to all adult age groups on the assumption that weight should not change at the older ages if activity is maintained! Recommended NIV based on NCHS/WHO data: For adults, it is recommended that the average weight of men and women at 18 years of age be used throughout the adult years rather than reflecting the typical secular increase in body weight with age. It is uncertain whether this secular increase is consistent with good health. For all nutrients (except energy), standard body weight uncorrected for overweight status is appropriate for estimating NIVs.! Atkinson and Koletzko. Food Nutr Bull 2007! Recent Reconsiderations of Micronutrient Reference Values! Commission of the European Communities! EURRECA EURopean micronutrient RECommendations Aligned! developing generic instruments for systematically deriving and! updating micronutrient reference values and dietary! recommendations! National Institute of Child Health and Human Development, NIH! BOND Biomarkers of Nutrition for Development! (i) identify, develop, and implement valid and reliable biomarkers! (ii) support harmonizing global health and nutrition communitiesʼ! decision-making process for determining which biomarkers are! most useful under defined conditions and settings! 20!
21 European Nutrigenomics Organisation (NuGo)! EC Research Directorate! Overall objective is linking genomics, nutrition and health research NuGO Nutrition Bioinformatics Infrastructure objectives: develop and maintain a nutritional phenotype database using a modular architecture which can be used in all types of nutrition and health research studies develop an integrated toolbox for study evaluation, replication of study interrogation and meta-analysis, and determine normal values for relevant parameters Growth of Nutrition in Proteomics and Systems Biology Publications! Moore and Weeks. Adv Nutr 2011! 21!
22 Multiscale Model for Nutrition and Insulin Resistance! De Graaf et al. PLOS Comput Biol 2009! Knowing is not enough; we must apply Willing is not enough; we must do.!!- Johann Wolfgang von Goethe ( )! IOM FNB. DRI Coverpage! 22!
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