Goal: To expand the capacity to strengthen the field of dietary supplement science and address emerging public health concerns
ODS will utilize its strengths in methodology and database content development to enhance its research capacity, serving as an integrated resource as knowledge gaps are identified and new collaborative research is developed. To ensure that research methods used in ODS-funded research are appropriate and rigorous, ODS staff will work with experts at NIH and in the field to develop a harmonized set of research methods best practices that can confidently be applied to a variety of dietary supplement research projects. Databases that support dietary supplement research and have been developed with ODS support will be maintained and modernized as needed to optimize their use by researchers and other audiences.
Research Capacity Objective 1
Strengthen and harmonize methodological approaches and promote scientific best practices in the design, conduct, and reporting of dietary supplement research
Dietary supplement research spans cell, animal, clinical, and population-based studies with numerous areas of focus. For example, studies to evaluate the health effects of dietary supplements focus on the underlying biological mechanisms of action and the safety and effectiveness of dietary supplement interventions. This includes preclinical and translational research to inform clinical trials. Research on exposure to dietary supplements in the United States uses population-based survey data to capture nutrient and dietary supplement intake. The correlation of dietary supplement intake with health outcomes depends on the identification and measurement of biomarkers of nutrient exposure, status, and function in relation to chronic disease in populations and individuals.
The ability to compare, reproduce, and replicate published research results is essential for building scientific knowledge. For dietary supplement research, this requires the development of best practice guidance for rigor, reproducibility, and transparency. This also requires methodological techniques that can be applied to a variety of research paradigms with a focus on research design, intervention development, measurement, and analysis.
Through its previous work, ODS has set groundwork for developing research best practices that can be applied to various types of dietary supplement research. For example, AMRM has enhanced the foundation for biomedical research on the health effects of nutrients and botanical constituents and their metabolites by advancing their analytical characterization in dietary supplements and clinical/biological samples. In addition to providing resources for assuring that scientifically valid analytical methods and well-characterized reference materials are available to interested parties, AMRM evaluates the resource needs of the dietary supplement community, maintains a repository of tools and information, and provides guidance to investigators on questions of natural product integrity.
To facilitate the use of appropriate and rigorous research paradigms for investigating the safety and efficacy of dietary supplements and their ingredients, ODS supports and organizes workshops on the latest knowledge and emerging approaches in the study of dietary supplements. ODS also encourages the development and use of appropriately validated biomarkers of nutrient status in ODS-supported studies of the health effects of dietary supplement ingredients. ODS has worked with CDC's NCHS and the USDA's Agriculture Research Service (ARS) Human Nutrition Research Center (HNRC) to develop tools to evaluate dietary supplement use more precisely in national health surveys and other large cohorts. As mentioned in the population research discussion, ODS will strengthen its collaborations with NIDDK, USDA NIFA, the Office of Nutrition Research (ONR), and the NIH Foundation, all of which are currently engaged in developing biomarkers of nutritional intake and nutrient status. ODS will collaborate with partners to develop appropriate recruitment and data collection methods to ensure that data on intake and dietary supplement use of all Americans are collected accurately.
Expanding existing ODS methodological resources, ODS will work to strengthen dietary supplement research. It will:
- Establish best practices to bolster experimental design and methodological rigor, reproducibility, and transparency applied to ODS- and NIH-funded dietary supplement research
- Develop projects to identify biomarkers of nutrient intake and status
- Develop population-based research designs and data collection tools to encourage broad participation to enhance the reliability and applicability of research outcomes
- Develop dietary supplement assessment methodology that links dietary supplement and nutrient intake data with food and supplement composition data
Research Capacity Objective 2
Identify and support innovative use of publicly available dietary supplement databases to inform and strengthen new research
More than 100,000 dietary supplements are on the market in the United States that contain nutrients (and often other bioactive ingredients) that may affect human health. These products also often contain "excipient" ingredients used in product formulation. Resources that provide documentation on each dietary supplement product and its composition are necessary for researchers, clinicians, and consumers to understand what is consumed and how those ingredients affect overall nutrient intake.
The Dietary Supplement Label Database (DSLD) was developed in collaboration with experts from NIH, CDC, NHANES/NCHS, the U.S. Food and Drug Administration (FDA), USDA, the Department of Commerce, and DoD. It contains virtually all information printed on dietary supplement labels including supplement facts information; other added ingredients such as fillers, binders, and flavorings; directions for use; health claims; and any listed cautions. It also contains images of product labels. Data in DSLD are used by researchers to more precisely identify dietary supplement ingredients consumed.
The Dietary Supplement Ingredient Database (DSID), a collaborative effort with the USDA HNRC, is a repository of reports that detail analytically validated supplement content measurements for estimating exposures to some of the most commonly consumed supplement product categories. To date, data are available for child, adult, and prenatal multivitamin/mineral supplements as well as calcium, vitamin D, omega-3 supplements, and caffeine. Dissolution and disintegration studies conducted on some categories of dietary supplements (e.g., calcium and green tea) have indicated potential efficacy gaps with implications for NIH research and individual usage. While DSID has made tremendous advancements by pairing analytical data with population-based data, future efforts will focus on using these resources to inform development of new research opportunities that reflect ODS research objectives and cross-cutting strategic priorities.
ODS has also developed and updated the Computer Access to Research on Dietary Supplements (CARDS) database that contains information on federally funded research projects of dietary supplements since 1999. Researchers and the public use CARDS to explore federal investments in dietary supplement research categorized according to dietary ingredient, health condition, and study type.
The focus of dietary supplement database work will be to:
- Maintain, update, and ensure continued public access to these databases
- Link databases directly with dietary intake assessment tools to provide data on nutrient and non-nutrient contributions of dietary supplements to total intake
- Utilize databases and existing partners to inform new ODS research