Project Number: 8040-52000-068-070-S
Project Type: Non-Assistance Cooperative Agreement
Start Date: Sep 30, 2021
End Date: Sep 29, 2026
The Dietary Supplement Ingredient Database (DSID) (http://dsid.usda.nih.gov; (U.S. Department of Agriculture, 2012) currently provides nationally representative supplement composition data for adult and children’s MVM, based on chemical analysis. All other dietary supplement databases contain label information only. In addition to the evaluation of vitamin and mineral levels in dietary supplements, the DSID has expanded to include supplements with other ingredients of interest, including omega-3 (n-3) fatty acids in fish and plant oil supplements, and catechins, caffeine, turmeric and proanthocyanidins in botanical supplements.
Several types of studies are planned, including ongoing national studies and studies evaluating the performance quality of Dietary Supplement (DS) dosage forms. Over the next year, DSID research will include: 1. Calcium-containing DS: For our nationally representative DSID study evaluating the analytical ingredient content of calcium-containing DSs begun in FY 2019, disintegration and dissolution testing of the products in the study will be completed in 2021 and final statistical analysis will be completed in 2022. This data will be used to plan a shelf-life study of calcium-containing DS. 2. Shelf life testing of a Calcium DS disintegration and dissolution: effects over time: The results of the disintegration and dissolution testing for the national Ca DSID study will be used to plan a study evaluating the performance quality of various dosage and ingredient forms for calcium DS at the beginning and near the end of shelf lives. New products will be purchased to test the same lot within 2 months of purchase and within 2 months of expiration. Magnesium will also be tested. 3. Over-the-Counter (OTC) Antacids: The goals of this project are to test OTC antacid products for their calcium and magnesium content and for new disintegration and dissolution test of chewable products, and determine if they meet United States Pharmacopeia (USP) standards. Products purchased for this study will be self-identified as antacids, intended for adults, and contain calcium = 200 mg per tablet. 4. Proanthocyanidin (PAC) content of cranberry DS: The quality of products containing cranberry powders and extracts is largely unknown for this popular DS category. This research has two objectives: evaluate popular cranberry DSs for their total PAC content, as analyzed by DMAC (4-di-methylaminocinnamaldehyde), a colorimetric assay that is the industry standard for voluntary label claims for total PAC content; and evaluate new developments in methodology for testing of PAC content by high performance liquid chromatography (HPLC) and high resolution mass spectrometry (MS), focusing on separating and quantifying A-type and B-type PAC content. 5. Content of L-5-methyltetrahydrofolate (L-5-MTHF), other folates and folic acid in DS: L-5-MTHF is the primary biologically active isomer of folic acid and the primary form of folate in serum. MTHF is starting to replace folic acid in some types of DS, especially prenatal MVM. It is marketed as a more bioavailable form of folic acid, and the percentage of DS products in the U.S. market with MTHF appears to be increasing. There have been concerns about the stability of MTHF and the label integrity of products listing this ingredient since is much more expensive than folic acid. Planning for this study is underway.