(CLOSED) NIH-RFA-OD-19-001 Botanical Dietary Supplements Research Centers (BDSRC) (U19 Clinical Trial Optional)

Sponsor Name: 
NIH
Amount: 
$3,600,000.00
Description of the Award: 

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.

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.

Excluded Research Areas

Projects proposing any of the following research will be considered nonresponsive and will not be reviewed:

See Section VIII. Other Information for award authorities and regulations.

  • Projects lacking evidence for a biologically and mechanistically plausible, reproducible effect(s) relevant to human resilience, with the effect(s) consistent across at least two independent and scientifically distinct lines of evidence.
  • Projects lacking justification for the importance of achieving the Specific Aims to the future design of a follow-on clinical trial.
  • Research involving models of chronic diseases or conditions where the focus is solely on treatment rather than on outcomes relevant to risk reduction, health maintenance or resilience.
  • Applications in which the Specific Aims do not focus on quantitative, objective outcomes relevant to human resilience.
  • Projects proposing clinical trials of efficacy or effectiveness.
  • Applications proposing to focus on parenteral or topical administration of interventions are generally beyond the scope of this FOA, as dietary supplements are intended to be orally ingested and swallowed. Applications proposing parenteral or topical administration may be considered responsive only where the outcome is demonstrably applicable to understanding the mechanism of action of orally ingested product.
  • Projects lacking rigorous data identifying one or more components of the botanical product or their metabolites as bioavailable and required for an in vivo bioactivity.
  • Projects lacking a proposed unbiased and rigorous approach to assess the potential presence of additional bioactives or in vivo targets, beyond those previously described, except where data from such an approach are previously reported and/or included as preliminary data.
  • Projects where the focus is a small number of largely purified phytochemicals. Minimally processed botanicals are within scope.
  • Projects focused on classical drug development.
  • Research on bacterial or yeast fermentation products as the delivered intervention. Aims focused on bioactives generated within a human or other animal by its microbiota would be in scope.
  • Research focused on the development of methods to improve large scale production of individual botanicals or their derivatives, or on synthetic approaches to modify botanicals or their components to improve bioavailability or potency.
Limit (Number of applicants permitted per institution): 
1
Sponsor Final Deadline: 
Apr 15, 2019
OSVPR Application or NOI Instructions: 

Interested applicants should send the following documents in sequence in one PDF file (File name: Last name_NIH 19-001_2019 no later than 4:00 p.m. on the internal submission deadline:

Cover Page must include:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)

2 page summary to include:

  • Identify the project scope that addresses the key aspects and elements outlined in the RFA solicitation, principal investigators, collaborators, and partner organizations.

Questions concerning the limited submissions process may be submitted to limitedsubs@psu.edu.

To be considered as a Penn State institutional nominee, please submit a notice of intent by the date provided directly below.
This limited submission is in downselect: 
Penn State may only submit a specific number of proposals to this funding opportunity. The number of NOIs received require that an internal competition take place, thus, a downselect process has commenced. No Penn State researchers may apply to this opportunity outside of this downselect process. To apply for this limited submission, please use this link:
OSVPR Downselect Deadline: 
Thursday, February 21, 2019 - 4:00pm
Notes: 
Lu, Junxuan (Pharmacology, COM) 2/21/19