2005 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? What does it matter? According to the latest Government surveys, at least 50% of the United States population reports that they have used dietary supplements. American consumers have been choosing 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. This intake of vitamins, minerals and other dietary supplements contributes to increased total consumption of these components from foods. For some individuals, supplements contribute a major and sometimes larger proportion of the intake of micronutrients or bioactive food components than diet alone. Dietary supplement databases have been developed to gather information about supplement products, but all of those databases have ingredient information only from the supplement manufacturer or distributor. The Nutrient Data Laboratory, at the Beltsville Human Nutrition Research Center, is responding to the need for a dietary supplement database that is supported by analytical data in a manner analogous to food databases. The Dietary Supplement Ingredient Database will be developed, validated and maintained at the United States Department of Agriculture to compile information which will be relevant to the scientific community, health professionals and the public. The ultimate goal of this project is to develop a validated database of representative values for dietary supplement products. 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. At the time the Human Nutrition Action Plan was written, the agency's mission did not include dietary supplement research. However, since that time, it has become apparent that the consumption of dietary supplements is 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 an increasing part of this trend, since most people take supplements specifically to optimize their health and prevent disease. 2.List the milestones (indicators of progress) from your Project Plan. 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 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 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 ingredient data from analytical labs 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 Implementation of large-scale project analyzing supplement products; 28.Develop unique sampling plans 29.Acquire samples and analyze 30.Evaluate analytical and QC data 31.Migrate supplement ingredient data from analytical labs into database 32.Develop and implement monitoring plans for specific dietary supplement product types 33.2nd data release 4a.What was the single most significant accomplishment this past year? Completion of first phase of pilot study work. Pilot studies 1 and 2 assessed and validated application of sample handling procedures for dietary supplements. The results enabled expansion of pilot study plans so that second tier of nutrients were determined, which is the next step of progress. The Tier 2 nutrients are thiamin, riboflavin, niacin, vitamin B6, vitamin B12, vitamin D, vitamin K, zinc, magnesium, selenium, iodine, copper, potassium, chromium, phosphorus, and manganese. The results from these studies will focus research for the rest of the project, including planning for study of a systematic relationship between nutrient label values and actual values for multivitamins and for the full-scale multi-vitamin study. 4b.List other significant accomplishments, if any. Completion of caffeine study. A caffeine study for the Food and Drug Administration and the Office of Dietary Supplements was conducted to provide preliminary information on prevalence of caffeine in dietary supplements. The study involved identification of about 60 representative caffeine-containing weight loss and sports products and laboratory analysis for caffeine, theobromine, and theophylline content, evaluating three lots of each product over a 9-month period. Rigorous quality control measures, including use of Standard Reference Materials, were implemented. Reports were prepared for presentation and publication. This project paralleled the pilot studies and was designed to optimize data collection, information gathering, and appropriate reviews. 4c.List any significant activities that support special target populations. Dietary supplements are consumed by populations across ethnic and socioeconomic groups. Data acquired through this study will be used to monitor total dietary intake and health status of various sub-populations. 5.Describe the major accomplishments over the life of the project, including their predicted or actual impact. The results thus far in identification of information needs and pilot studies are essential for the development of the analytically based dietary supplement database. Extensive evaluation of survey data on dietary supplement frequency of use provided detailed exposure information for hundreds of ingredients in dietary supplements. A statistical sampling plan for multi-vitamin/mineral products based on levels of specific ingredients was developed. Several pilot studies have been conducted and more studies are planned to develop valid analytical infrastructure for the main phases of the project. Initial pilot studies assessed and validated application of sample handling procedures and laboratory methods for Tier 1 nutrients using samples sent for analysis to reliable laboratories. The results enabled determination of specific second tier nutrients, which is the next step of progress. 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? NDL analyzed, combined and converted several large publicly available datasets into a simpler, easier to use subsets for specific purposes. In NDL's dataset, the ingredients in vitamin and mineral containing dietary supplement products were converted to common units of measure so that they could be easily sorted and compared. This dataset was then shared with a federal collaborator, at their request. The first release of the DSID, a publicly available database, which will contain a mix of data types and product types, is scheduled for FY2007. The DSID will be available on NDL's website, www.nal.usda.gov/fnic/foodcomp. Research methodologies and results will be published in scientific journals and discussed at scientific conferences in an effort to maximize visibility to stakeholders and the research community. Since this information will be released on the Internet, it will be available to both scientists and consumers. The information will be updated and expanded as new data are generated. Long-term monitoring activities will be established to incorporate data for new dietary supplements, reformulations of existing supplements, new analytical methodologies and changes in intakes and trends. There are not obvious constraints to the transfer of this technology. 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). Dwyer, J.T., Picciano, M.F., Betz, J.M., Saldanha, L.G., Coates, P.M., Radimer, K., Bindewald, B., Holden, J., Harnly, J., Wolf, W., Andrews, K., Zhao, C. Development of an Analytically Validated Dietary Supplement Ingredient Database (DSID) for Use in Quantifying Nutrient Contributions from Supplements to Total Dietary Intakes. Accepted for presentation at the International Food Data Conference, Pretoria, South Africa, September 2005. Andrews, K.W., Holden, J., Roseland, J., Zhao, C., Schweitzer, A., Harnly, J., Wolf, W., Perry, C.R., Dwyer, J.T., Picciano, M.F., Betz, J.M., Saldanha, L.G., Yetley, E., Fisher, K., Sharpless, K. Pilot Studies for the Development of an Analytically Validated Dietary Supplement Ingredient Database. Accepted for presentation at AOAC Annual Meeting. Orlando, FL. September 2005. Zhao, C., Andrews, K.W., Holden, J., Schweitzer, A., Roseland, J., Harnly, J., Wolf, W., Dwyer, J.T., Picciano, M.F., Betz, J., Saldanha, L., Yetley, E., Fisher, K., Radimer, K. Antioxidant Supplements Reported in the National Health and Nutrition Examination Survey (NHANES) 1999-2000, American Institute for Cancer Research Annual Meeting. Washington, DC. July 2005 Schweitzer, A., Zhao, C., Andrews, K.W., Holden, J., Perry, C.R., Harnly, J., Wolf, W., Dwyer, J.T., Picciano, M.F., Betz, J.M., Saldanha, L.G., Yetley, E., Fisher, K., Sharpless, K, Radimer, K., Bindewald, B. Dietary Supplement Ingredient Database Project: Initial Evaluation of High Priority Nutrients in Multivitamin/Multimineral Supplements. Beltsville Area Research Center Poster Day, June 2005. Andrews, K.W., Zhao, C., Holden, J., Perry, C.R., Schweitzer, A., Wolf, W., Harnly, J., Dwyer, J.T., Picciano, M.F., Saldanha, L.G., Fisher, K., Betz, J.M., Yetley, E., Radimer, K., Bindewald, B. Selection of Representative Multivitamin Products Based on % Daily Value Levels for Specific Nutrients. Experimental Biology Conference. San Diego, CA. April 2005 Andrews, K.W., Zhao, C., Holden, J., Schweitzer, A., Harnly, J., Wolf, W., Dwyer, J.T., Picciano, M.F., Betz, J.M., Saldanha, L.G., Yetley, E., Fisher, K., Radimer, K., Bindewald, B. A Review Of Multivitamin/Multimineral Supplement Products Reported in the National Health and Nutrition Examination Survey (NHANES) 1999-2000. National Databank Conference. San Diego, CA. April 2005. Holden, J., Andrews, K.W., Zhao, C, Schweitzer, A., Perry, C.R., Harnly, J, Wolf, W., Dwyer, J.T., Picciano, M.F., Saldanha, L.G., Yetley, E., Fisher, K., Sharpless, K., Radimer, K., Bindewald, B. Dietary Supplement Ingredient Database Project: Protocol Development. Experimental Biology Conference. San Diego, CA. April 2005. Dwyer, J.T., Picciano, M.F., Betz, J.M., Saldanha, L.G., Coates, P.M., Radimer, K., Bindewald, B., Holden, J., Harnly, J., Wolf, W., Andrews, K.W., and Zhao, C. Development of an analytically validated dietary supplement ingredient database (DSID) for use In quantifying nutrient contributions from supplements to total dietary intakes. American Dietetic Association Annual Meeting. Anaheim, CA. October 2004. Review Publications Bhagwat, S.A., Haytowitz, D.B., Prior, R.L., Gu, L., Hammerstone, J., Gebhardt, S.E., Kelm, M., Cunningham, D., Beecher, G.R., Holden, J.M. 2004. Usda database for proanthocyanidin content of selected foods. Home Page. http://www.nal.usda.gov/fnic/foodcomp. Cutrufelli, R.L., Pehrsson, P.R., Patterson, K.K., Wilger, J., Haytowitz, D.B., Holden, J.M. 2004. USDA national fluoride database of selected beverages and foods. Home Page. http://www.nal.usda.gov/fnic/foodcomp. Gebhardt, S.E., Pehrsson, P.R., Lemar, L.E., Haytowitz, D.B., Cutrufelli, R.L., Howe, J.C., Holcomb, G.T., Exler, J., Thomas, R.G., Showell, B.A., Holden, J.M. 2004. USDA National nutrient database for standard reference, release no. 17. Home Page. http://www.nal.usda.gov/fnic/foodcomp Haytowitz, D.B., Cutrufelli, R.L., Lemar, L.E., Thomas, R.G. 2004. The USDA national nutrient database for windows, SR17. Home Page. http://www.nal.usda.gov/fnic/foodcomp Haytowitz, D.B., Cutrufelli, R.L., Lemar, L.E., Thomas, R.G. 2004. The USDA national nutrient database for personal digital assistants (PDAs), rel. 17. Home Page. http://www.nal.usda.gov/fnic/foodcomp. Haytowitz, D.B., Gebhardt, S.E., Pehrsson, P.R., Lemar, L.E., Cutrufelli, R.L., Howe, J.C., Holcomb, G.T., Exler, J., Thomas, R.G., Showell, B.A., Holden, J.M. 2004. USDA national nutrient database for standard reference, release No. 17 - CD-ROM. Koontz, J., Phillips, K., Wunderlich, K., Exler, J., Holden, J.M., Gebhardt, S.E., Haytowitz, D.B. 2005. Comparison of total folate concentration in foods determined by microbiological assay at several experienced laboratories. Journal of Association of Official Analytical Chemists International. 88(3):805-813.