RFA-OD-19-001: Botanical Dietary Supplements Research Centers (BDSRC) (U19 Clinical Trial Optional)
Internal Deadline: February 15, 2019, noon PT
LOI: 30 days prior to the application due date
External Deadline: April 15, 2019, by 5:00 PM local time
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: Issuing IC and partner components intend to commit an estimated total of $3.6 million to fund three awards.
Anticipated Amount: Application budgets are limited to $1.2 million total costs per year, but need to reflect the actual needs of the proposed project. F&A on consortia must be included within the $1.2 million total costs.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
This funding opportunity announcement (FOA), for one component of the NIH Consortium for Advancing Research on Botanicals and other Natural Products (CARBON) Program, represents an evolution of the previous Botanical Dietary Supplements Research Centers FOA, RFA OD 14-001. The goal of the consortium is to advance methodology for, and conduct research on, complex natural products. This Botanical Dietary Supplements Research Centers (BDSRC) component of the CARBON will support transdisciplinary collaborations focused on producing the most critical data to inform the optimal design of future clinical trials of orally consumed, complex botanical dietary supplements for which there are rigorous but not definitive preliminary data. The preliminary data provided by responsive applications must support a reproducible, physiologically and mechanistically plausible, and statistically and clinically significant effect on, or relevant to, human biological or cognitive/behavioral, objectively measured resilience. Applications in which a purified phytochemical is the main focus will be considered nonresponsive. Achievement of the BDSRC Specific Aims is expected to contribute critical information for the design of optimally informative clinical trials. Results from the BDSRC might, for example, be targeted to inform decisions related to specific trial design, product formulation(s), doses, timing, eligibility criteria, data to be collected, markers of proximal biological effect, outcome measures, etc. This FOA cannot, itself, be used to support clinical trials of efficacy or effectiveness. Applications proposing such trials will be considered nonresponsive. Each BDSRC will be required to include a Botanical Research Core, two research projects that synergize with each other and with the Core, and plans for supporting research training.
The purpose of this BDSRC FOA is to support research to develop additional information most critical to the optimal design of, and decision-making for clinical trials of the effects of ingested, complex botanical products on quantitative, objective, well-validated indicators relevant to biological or cognitive/behavioral resilience. Responsive applications must provide rigorous evidence supporting a biologically and mechanistically plausible, reproducible effect, the magnitude of which is sufficient to justify a human intervention trial. The evidence provided, whether newly developed or in peer-reviewed research publications, must be consistent across at least two independent and scientifically distinct (e.g., orthogonal) lines of evidence, and must include data that address causality (e.g., results of knock-out and/or over-expression designs). For example, data from an in vitro model (using a physiologically relevant product and concentration) supporting a mechanism of action, and data from an early-phase clinical trial, consistent with the in vitro results, as well as with a correlation between the mechanism of action and the physiological or cognitive/behavioral outcome of interest, would be responsive. Data from two different product doses, both in the same pre-clinical model, would not be sufficient support for a responsive application.
Research objectives supported by this FOA may include, but are not limited to:
- Obtaining additional data on the causal, molecular mechanism through which the bioactive component(s) of the product act(s) on the proximate in vivo target(s). Model systems used, whether in silico, in vitro or in vivo, must be well-validated and well-justified as appropriate for the research question posed.
- Obtaining data on genetic or epigenetic sources of diversity in human responses to the intervention, and their underlying causal, molecular mechanisms. The contributions of age, sex, diet, and/or differences in gut microbiota to such differences are of particular interest.
- Further elucidation of the mechanisms through which the proximate biological activity(ies) of the product are effected, or through which they generate the hypothesized health outcome.
- Generation of data on dose-response, optimal product composition, pharmacokinetics/pharmacodynamics (PK/PD) and optimal dose regimen, and/or optimization of circadian timing of intervention.
- Generation of data on the time course of a health effect.
Visit our Institutionally Limited Submission webpage for updates and other announcements.