At a glance
This program funds early-phase clinical trials of natural products, including botanicals, probiotics, dietary supplements, and standardized nutritional regimens, to study how they affect a biological target and whether that target change is linked to clinical outcomes. Applicants must propose both an R61 phase and an R33 phase, with the R61 testing target engagement and often pharmacokinetics, and the R33 replicating the target effect and examining its link to clinical outcomes; R33 funding depends on meeting R61 milestones and go/no-go criteria. The announcement does not state a specific award size or number of awards. Studies using waitlist controls, animal studies, cancer treatment or prevention trials, synthetic derivatives, or projects that do not include target engagement are not responsive, and the notice highlights priority areas such as sleep, pain, gastrointestinal disorders, PASC, mental health, gut microbiome-brain interactions, cannabinoids, psychedelics, minority health, HIV-related complications, and dietary intake or nutritional status effects.
What it funds
Official description from grants.gov
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments