The purpose of this Notice is to inform potential applicants that the National Heart, Lung, and Blood Institute (NHLBI) is participating, effective immediately, in PA-20-227, “Administrative Supplements for Research on Dietary Supplements (Admin Supp Clinical Trial Not Allowed).
The following text (italicized) has been added to reflect NHLBI's participation in this FOA:
Part 1. Overview Information
Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.837, 93.838, 93.839, 93.840, 93.233
Part 2. Section I. Funding Opportunity Description
Specific Areas of Research Interest
NHLBI Areas of Interest
Topics/studies of interest to the NHLBI include, but are not limited to, those listed below:
- Studies that assess dietary supplement use in NHLBI cohort studies
- Studies that examine biomarkers of dietary supplement use in randomized controlled trials.
- Evidence-based evaluations of the role of dietary supplements, including evaluation of the safety and efficacy of dietary supplement use in the prevention and reduction of risks for HLBS diseases and conditions.
- Studies that examine circadian-based mechanisms and strategies that improve the efficacy of dietary supplements on heart, lung, blood and sleep pathobiology and clinical outcomes.
- Studies that examine the beneficial effects of botanical dietary supplements and their role in influencing the gut microbiome.
- Utilization of “omics” technologies such as metabolomics or proteomics to evaluate biomarkers of total nutrient intake (from diet and dietary supplements) in NHLBI cohort studies or projects that add novel biomarkers to randomized controlled trials of dietary supplements.
- Studies that investigate the contrasting effects of dietary supplements on certain diseases or health conditions
- Intervention studies that examine the effects and mechanism of action of dietary supplements on maintenance of optimal cardiovascular health or reduction of disease risk where supplement interventions alter physiological endpoints or other health outcomes (e.g., a study that examines the physiologic or mechanistic effects of COQ10 on heart failure outcomes).
- Studies of single ingredients or complex mixtures that examine the transport, metabolism, mechanism of action, associated enzymes, binding sites, regulatory mechanisms or excretion of dietary supplements in order to elucidate their physiological or biochemical role of a supplement related to HLBS diseases.
Examples of research projects that fall outside the scope of Office of Dietary Supplements (ODS) and this Notice of NHLBI Participation:
- Studies that do not give the supplement by mouth.
- Studies that administer the supplement to treat a disease process or outcome such as atherosclerosis or depression without evaluation of the supplement’s effect on the underlying mechanisms of action, bioavailability, or metabolic pathways.
- Human, animal, or laboratory studies that correlate physiological levels of dietary supplement ingredients, their metabolites, or marker compounds with disease risk, physiological endpoints, or other health outcomes without the administration of a dietary supplement (e.g., a human study correlating serum levels of 25-hydroxyvitamin D and risk of hip fracture or a human study correlating serum levels of folate and cardiovascular disease).
- Studies evaluating the effect of whole foods that could be considered “functional foods” such as broccoli and other cruciferous vegetables, garlic, soy, and flaxseed. However, if a food ingredient in a defined form is being investigated (e.g., a garlic capsule, a soy or phytoestrogen supplement, EGCG in a green tea supplement, or dried ginger root in a tea bag), then the study could be within the scope of this Notice.
- Studies that involve dietary ingredients used to treat inborn errors of metabolism, such as a study investigating the use of tyrosine to treat phenylketonuria. However, if the research is focused on identifying the mechanism of action, it could be considered within the scope of this Notice.
- Studies of compounds that are classified as drugs, such as the hormones estrogen, progesterone, and insulin.
- Studies that focus solely on Clinical trials.