2006 Annual Report 1.What major problem or issue is being resolved and how are you resolving it (summarize project aims and objectives)? How serious is the problem? Why does it matter? At the time the Human Nutrition Action Plan was written, the agency's mission did not include dietary supplement research. However, consumption of dietary supplements is now an integral part of the nutrient consumption in this country. In the Action Plan 107, Component 4, Composition of Foods, Performance Goal 3.1.2 for food composition and consumption, there is a requirement to "develop techniques for determining food composition, maintain national food composition databases, [and] monitor the food and nutrient consumption of the United States population." In addition, the Action Plan discusses the fact that the national nutrition focus is shifting from the prevention of nutrient deficiencies to emphasizing health and reducing disease risk. The use of dietary supplements is increasingly a part of this trend, since most people take supplements specifically to optimize their health and prevent disease. According to the latest Government surveys, at least 50% of the United States population reports that they have used dietary supplements. American consumers choose to take supplements of vitamins, minerals, amino acids, fatty acids, botanicals, and other types of products for their alleged health effects. In 2002 alone, sales in the dietary supplement industry were over $18 billion. The intake of dietary supplements containing vitamins, minerals, and other components contributes to the total intake of these nutrients. For some individuals, supplements contribute a larger proportion of the intake of micronutrients or bioactive food components than diet. Dietary supplement databases provide information about supplement products, but these databases only contain composition data derived from manufacturer labels. The Nutrient Data Laboratory (NDL), at the Beltsville Human Nutrition Research Center, is responding to the need for a dietary supplement database supported by analytical data in a manner analogous to food databases. The goal of this project is a Dietary Supplement Ingredient Database developed, validated and maintained at the United States Department of Agriculture to provide information that will be relevant to the scientific community, health professionals and the public. One of the primary uses of this database will be for estimating the U.S. intake of vitamins, minerals and other ingredients of dietary supplements. The specific aims for the Dietary Supplement Ingredient Database (DSID) project are. 1)to identify and review current sources of data,. 2)to identify and rank dietary supplements for priority in sampling and analysis,. 3)to develop and conduct analytical programs for specific product types,. 4)to develop a structure for the database,. 5)to compile and distribute data to the scientific community and to the public, and. 6)to develop and implement a monitoring plan for database updates. 2.List by year the currently approved milestones (indicators of research progress) Year 1 (FY 2004) 1.Rank supplement products by category and ingredient. 2.Assess quality of existing data. 3.Develop sampling frame for nationwide sampling. Project analyzing caffeine-containing products 4.Develop sampling plan. 5.Acquire samples and analyze. Implementation of large-scale project analyzing supplement products 6.Develop unique sampling plans. 7.Acquire samples and analyze. Year 2 (FY 2005) 8.Identify and qualify analytical labs. 9.Define quality control program. 10.Define database structure. Project analyzing caffeine-containing products 11.Evaluate data. Implementation of large-scale project analyzing supplement products 12.Develop unique sampling plans. 13.Acquire samples and analyze. 14.Evaluate analytical and quality control (QC) data. 15.Develop monitoring plan for database. 16.Finalize database structure and develop file formats. Year 3 (FY 2006) 17.Rank supplement products by category and ingredient using newest version of National Health and Nutrition Examination Survey (NHANES) data. 18.Preliminary data release. 19.Migrate supplement ingredient data from analytical labs into database. 20.Develop and implement monitoring plans for specific dietary supplement product types. Year 4 (FY 2007) Implementation of large-scale project analyzing supplement products 21.Develop unique sampling plans. 22.Acquire samples and analyze. 23.Evaluate analytical and QC data. 24.Migrate supplement analytical data into database. 25.Develop and implement monitoring plans for specific dietary supplement product types. 26.1st data release. Year 5 (FY 2008) 27.Rank supplement products by category and ingredient. 28.Develop unique sampling plans. 29.Acquire samples and analyze. 30.Evaluate analytical and QC data. 31.Migrate supplement analytical data into database. 32.Develop and implement monitoring plans for specific dietary supplement product types. 33.Second data release. 4a.List the single most significant research accomplishment during FY 2006. The large scale pilot study called the percent Daily Value(%DV) study was completed. The %DV study assessed the relationship between analytical and label values of 23 nutrients in about 220 representative multivitamin/minerals (MVM). Laboratory analysis of double lots of 4 nutrients at 3 DV levels for 6 products per nutrient was also conducted. The results provided valuable information regarding laboratory variability per nutrient and per lot, as well as labeled versus analytical value per nutrient at specific DV levels. The findings from this study enabled development of the adult multivitamin/mineral study plans regarding analysis protocols for specific nutrients at the contract laboratory and specialty labs. Data from the %DV study were evaluated for any systematic relationships between nutrient label values and actual values for multivitamins and for applications to future studies. Characteristics of the products analyzed in the %DV study were recorded, and systems of categorizing MVM products by numbers of nutrients and by types such as mens', womens', mature, standard, and specialty were implemented. Reports were prepared and presented at professional meetings including Federation of American Societies for Experimental Biology, International Conference on Dietary Assessment Methods, and International Food Data Conference. 4b.List other significant research accomplishment(s), if any. Phase I of the adult MVM study was planned and initiated. Information gained from the pilot studies was applied to planning the adult MVM study to optimize sample selection, data collection, data evaluation, and appropriate reviews. A sampling plan was developed using market data and was cross-referenced with NHANES and other survey records to select representative MVMs from appropriate market channels. The first phase of the adult MVM study involved identification of 35 top-selling adult MVMs representing the most popular adult MVM products in the U.S. Samples were sent to the laboratory for analysis of 22 nutrients, evaluating six lots of each product from different geographic regions of the U.S. Rigorous quality control measures, including use of standard reference materials, were implemented. 4c.List significant activities that support special target populations. None. 5.Describe the major accomplishments to date and their predicted or actual impact. NDL is working with the Office of Dietary Supplements (ODS), National Institutes of Health (NIH), to plan and develop a Dietary Supplement Ingredient Database to monitor the ingredients in dietary supplement products. For this work, nutrients and components in dietary supplements were prioritized for analysis based on usage, research interest, public health significance, and the availability of adequate analysis methods. Several pilot studies were conducted to assess market share and sales channel information, to develop procedures for purchasing, storing and shipping of products and analytical samples, to test and select qualified laboratories, to validate methods for handling and analysis of samples, and to evaluate quality control procedures for 12 vitamins and 11 minerals found in a MVM matrix. The findings from these studies were used as the foundation for later studies. A subsequent large-scale %DV study was conducted to test for any systematic relationships between label values and analytical values for nutrients in about 220 MVM products. The analytical laboratory data from the study were used to assess the nutrient variability between and within products and to plan a comprehensive study of nutrient levels in representative adult MVM products. High prevalence of dietary supplement use in the U.S. (over 50% of the population surveyed) makes it critical to monitor the intake and actual composition of these products. Currently, nutrient content of dietary supplements is available only in label-based databases. The Dietary Supplement Ingredient Database (DSID) will provide analytical estimates of amounts of various components in dietary supplements. With these data obtained from the DSID, scientists will be able to more accurately estimate total nutrient intake from foods and supplements and to assess the relationship of intake to specific health outcomes. This freely available database will give healthcare professionals and consumers access to information for making informed dietary supplement choices. 6.What science and/or technologies have been transferred and to whom? When is the science and/or technology likely to become available to the end-user (industry, farmer, other scientists)? What are the constraints, if known, to the adoption and durability of the technology products? Posters and presentations were given at professional scientific meetings summarizing results of laboratory data from analysis of dietary supplement products in the pilot studies conducted by NDL. 7.List your most important publications in the popular press and presentations to organizations and articles written about your work. (NOTE: List your peer reviewed publications below). Holden, J.M., Andrews, K., Roseland, J.M., Zhoa, C., Schweitzer, A., Wolf, W.R., Harnly, J.M., Perry, C., Dwyer, J., Saldanha, L., Picciano, M., Fisher, K., Yetley, E., Betz, J., Radimer, K., Bindewald, B., Sharpless, K. What more do we need to know? Research update: The dietary supplement ingredient database: Results of USDA pilot studies. American Dietetic Association Annual Meeting: Food and Nutrition Conference and Expo, October 24, 2005, St. Louis, Missouri. Andrews, K., Schweitzer, A., Zhao, C., Holden, J.M., Roseland, J.M., Brandt, M., Spease, C., Woo, J., Dwyer, J., Picciano, M., Saldanha, L., Fisher, K., Betz, J., Yetley, E. Caffeine, theobromine and theophylline content of commonly purchased weight loss and sports performance enhancing dietary supplements. Experimental Biology, April 1-5, 2006, San Francisco, California. Holden, J.M., Zhao, C., Roseland, J.M., Andrews, K., Schweitzer, A., Perry, C., Wolf, W.R., Dwyer, J., Picciano, M., Saldanha, L., Fisher, K., Betz, J. Prevalence of vitamins E and B12 in dietary supplements reported in National Health and Nutrition Evaluation Survey (NHANES). Sixth International Conference on Dietary Assessment Methods, April 27-29, 2006, Copenhagen, Denmark. Roseland, J.M., Holden, J.M., Schweitzer, A., Andrews, K., Zhao, C., Brandt, M., Woo, J., Dwyer, J., Picciano, M., Saldanha, L., Betz, J. Caffeine-containing ingredients in dietary supplements: guarana, kola nut, yerba mate, tea, and cocoa. American Dietetic Association Annual Meeting, and Food and Nutrition Conference & Expo, September 16-19, 2006, Honolulu, Hawaii. Holden, J.M., Roseland, J.M., Andrews, K., Zhao, C., Schweitzer, A., Harnly, J.M., Wolf, W.R., Perry, C., Dwyer, J., Picciano, M., Saldanha, L., Betz, J. USDA Dietary Supplement Ingredient Database (DSID): Adult Multivitamin/Mineral Study. National Nutrient Databank Conference, September 18-20, 2006, Honolulu, Hawaii. Review Publications Dwyer, J., Picciano, M., Betz, J., Leila, S., Holden, J.M., Andrews, K.W., Cuiwei, Z., Harnly, J.M., Wolf, W.R., Perry, C. 2006. Progress in development of an integrated dietary supplement ingredient database at the NIH Office of Dietary Supplements. Journal of Food Composition and Analysis. 19:S108-S114.