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Pilot Study Protocols for Validation of Vitamin and Mineral Analysis In The Dietary Supplement Ingredient Database: Results of USDA Pilot Studies Presented by Joanne M. Holden, USDA, Agricultural Research Service, Nutrient Data Laboratory Agricultural Research Service USDA Authors Joanne Holden, Karen Andrews, Janet Roseland, Cuiwei Zhao, Amy Schweitzer, Nutrient Data Laboratory Wayne Wolf and James Harnly Food Composition Laboratory Charles Perry National Agriculture and Statistics Service NIH Authors Johanna Dwyer, Leila Saldanha, Mary Frances Picciano, Kenneth Fisher, Elizabeth Yetley, Joseph Betz Office of Dietary Supplements National Institutes of Health CDC and NIST Authors Kathy Radimer and Bernadette Bindewald National Center for Health Statistics, Centers for Disease Control and Prevention, US Department of Health and Human Services Kathy Sharpless National Institute of Standards and Technology Assessment of Intake Supplement FoodFood ComponentComponent Intake IntakeIntake ValuesValues TotalTotal ComponentComponent IntakeIntake USDA Database Products USDA National Nutrient Database for Standard Reference Database for national food and nutrition surveys Database for bioactive components Factors, guidelines, and protocols NDL’s Foodcomp Web site www.nal.usda.gov/fnic/foodcomp NHANES: What We Eat in America National Health and Nutrition Examination Survey of nearly 5,000 individuals annually Food intake assessed with two 24- hour dietary recalls Supplement intake assessed over past month DS nutrient values obtained from labels Assessment of Vitamin - Mineral- Intake for Foods FOODS Standard Reference (SR) Food and Nutrient Database for Dietary Studies (FNDDS) NHANES Food Intake Data NHANES Nutrient Intake Reports Assessment of Vitamin -Mineral Intake for Foods and Dietary Supplements FOODS DIETARY SUPPLEMENTS Standard Reference (SR) NHANES Dietary Supplement Label Database Dietary Food and Nutrient Supplement NDL Research Database for Ingredient Findings Dietary Studies Database (DSID) (FNDDS) NHANES Food Intake Data NHANES Supplement Intake Data NHANES Food Nutrient Reports Supplement Ingredient Intake Data Total Intake of V + M NHANES Dietary Supplement Database Database contains 6000+ products reported by respondents Products include multivitamins, single vitamins/minerals, botanicals, amino acids Nutrition information in database is based on label values Partnership with NCHS Today’s Objectives Goals for a DSID Key Challenges Pilot Study Questions Pilot Study Accomplishments Future Plans Goals for Dietary Supplement Ingredient Database To develop reliable estimates of nutrients and other bioactive components in Dietary Supplements To release and maintain on-line DS database To assess variability and/or possible bias in nutrient levels for DS Key Challenges Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Categorizing Product Types Defining a dietary supplement Classifying various dietary supplements available Defining a multivitamin/multimineral (MVM) Partners with NCHS Diverse Product Types Multivitamins Sport performance Condition-specific products products: joint Specialty health, bone products: amino health, memory acids, enzymes, Botanicals melatonin, plant Weight-loss oils, glucosamine, products probiotics Distribution of Vitamin Count in Adult Multivitamin/Minerals* 60 50 40 of Use (/1,000,000) 30 20 Weighted Frequency 10 0 3 4 5 6 7 8 9 1011121314151617 Number of Vitamins *Distribution of vitamins (>2) indicates that the most commonly reported adult multivitamins (NHANES 1999-2000) contain 13 vitamins. Distribution of Mineral Count in Adult Multivitamin/Minerals* 70 60 50 40 000) 30 1,000, / ( 20 10 Weighted Frequency of Use 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Number of Minerals *Distribution indicates that most products reported (NHANES 1999-2000) are either single or double mineral products or are multivitamin/mineral products with 16 minerals. Identifying priority components CriteriaCriteria considered:considered: FrequencyFrequency ofof consumption:consumption: NHANESNHANES PublicPublic healthhealth significancesignificance StatusStatus ofof methodsmethods andand referencereference materialsmaterials FederalFederal agencyagency interestinterest Highest Priority Categories Multivitamins/minerals(MVMs) Antacids Calcium Supplements Vitamin E Vitamin C B Vitamin products Caffeine-containing products Highest Priority “Tier 1” Ingredients Folic Acid/folate Calcium Vitamin E Vitamin A (Retinol) Vitamin C Iron Beta Carotene “Tier 2” Ingredients Riboflavin Potassium Thiamin Copper Niacin Selenium Vitamin B6 Chromium Vitamin B12 Manganese Vitamin D Magnesium Vitamin K Zinc Phosphorus Iodine Representative Sampling Plans Identify products: NHANES Select across distribution channels Mass market retail Natural food and health stores Multi-level marketing Direct sales Specific Methodology Issues for MVMs Unique matrix effects of capsules, pills, and gel caps Sample handling of MVMs for accuracy and precision Selection of valid methods Development of reference material Qualifying labs Development of Reference Materials (RMs) RM (known value) is measured along with sample MVM (unknown value) NIST is developing an RM for DS ODS, NIST, and FCL are partnering with NDL to: Characterize SRMs Review analytical methods Qualify labs Pilot Study Goals Pilot Study 1: Survey laboratories for standard analytical methods. Identify sample handling protocols for MVMs to insure complete recovery. Pilot Study 2: Assess capabilities of qualified labs to determine nutrient values of MVMs. Alpha-tocopherol Values for 2 Multivitamin/minerals and a Reference Material 45.00 40.00 35.00 mg/g A 30.00 Label Value 25.00 l 20.00 pha-tocopherol 15.00 10.00 Label Value 0.15 0.12 0.09 0.06 0.03 0.00 MVM 1 MVM 2 Reference Material Products Analyzed Lab 1 Lab 2 Lab 5 Lab 6 Known Value Levels of Alpha Tocopherol in Food and Supplements 1 Tbsp safflower oil = 5 mg alpha tocopherol* in natural form = 37% DV 1 oz dry roasted almonds = 7 mg alpha tocopherol* in natural form = 52% DV Common MVM = 30 IU (13.5 mg) synthetic alpha tocopherol = 100% DV *U.S. Department of Agriculture, Agricultural Research Service. 2005. USDA National Nutrient Database for Standard Reference, Release 18. Nutrient Data Laboratory Home Page, http://www.nal.usda.gov/fnic/foodcomp, Accessed October 19, 2005 Coefficient of Variation (%) for Laboratories Analyzing Tier 1 Nutrients in a Multivitamin/mineral Product 35 % ( 30 n o i at 25 i r a 20 V f o t 15 en ci i 10 f ef o 5 C 0 Folic acid A- Iron Ascorbic Calcium B- Retinol tocopherol Acid Carotene Nutrients Key Accomplishments Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Key Accomplishments Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Key Accomplishments Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Key Accomplishments Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Key Accomplishments Categorization/ Identifying Description Priorities Sample Handling Representative DSID Sampling Plans Unique Matrix Qualified Labs Methods and Reference Materials Next Steps: The “% DV” study Compare label and actual values of MVMs. Choose products at 3 or 4 DV levels. Analyze 5 products from each DV level. Measure 2 lots per product. Example: Most Common % DV Levels for Calcium in Adult Multivitamins 100 80 60 40 %of weighted frequency of use* 20 0 16% 20% 45% % DV of Calcium Calcium *NHANES 01-02 Example: Most Common % DV Levels for Vitamin C in Adult Multivitamins 100 80 60 40 % of weighted 20 frequency of use* 0 100% 200% 417% % DV of Vitamin C *NHANES 01-02 Vitamin C 18 Com V 0 D 16 , % 0 14 y Data p or 0 ar at 12 0 is 10 al Labor on of % etic 0 Theor 80 60 40 DV Labe 20 Theoretical Results 50-1 l Cl 50-2 aim P 50-3 s r vs. Laboratory oduc 50-4 50-5 ts l a 100-1 be 100-2 led at 5 100-3 Data, 100-4 0 , 100 100-5 ,15 150-1 0 150-2 % D 150-3 V 150-4 150-5 Application of Pilot Study Results Plans to analyze representative MVMs to support estimates for MVMs reported in NHANES. Validate composition data for generic classes of dietary supplements. USDA Database Products USDA National Nutrient Database for Standard Reference Database for national food and nutrition surveys Database for bioactive components Factors, guidelines, and protocols Dietary Supplement Ingredients Database Summary Pilot studies can refine questions and focus research for the development of a dietary supplement ingredient database. Acknowledgements Funded by Office of Dietary Supplements, National Institutes of Health http://Nutrition.gov http://ods.od.nih.gov DSID group Questions?.
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