Botanical Dietary Supplements Research Centers (U19 Clinical Trial Optional)

Through this Funding Opportunity Announcement (FOA), the participating components invite applications to support Botanical Dietary Supplements Research Centers (BDSRC), which will constitute one component of the Consortium for Advancing Research on Botanicals and Other Natural Products (CARBON.2). The purpose of the BDSRC is to support collaborative, trans-disciplinary research that will contribute significantly to the optimal design of future clinical trials of the effects on human resilience of orally consumed, complex botanical products. The BDSRC are expected to focus on developing the most critical data to inform the optimal design of such future trials. Information acquired through achievement of the BDSRC specific aims is expected to allow for the design of optimally informative clinical trials, providing evidence for design decisions including, but not limited to, decisions about the appropriateness of the trial design (or of doing any trial with the product), as well as those regarding product formulations, doses, timing, eligibility criteria, participant characteristics to be collected, markers of proximal biological effect, outcome measures, etc. Products appropriate for applications responsive to the planned FOA will be limited to those for which there is rigorous, but not definitive, evidence supporting a clinically or public health significant, biologically and mechanistically plausible, and reproducible effect on, or relevant to, human biological or psychological resilience. Applications in which a purified phytochemical is the main focus will be considered unresponsive to the FOA. Applicants applying under this BDSRC FOA are encouraged to collaborate, as appropriate, with other CARBON.2 components, including the NMR Open Data Exchange (NODE) and the Center for Natural Product Technology, Methodology and Productivity Optimization (NP-TEMPO), as well as with other NCCIH, ODS, and NIH supported grantees.