The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
This Notice of Funding Opportunity (NOFO) aims to encourage applications for investigator-initiated, early phase clinical trials of natural products such as botanicals, dietary supplements, and probiotics. The NOFO is designed to support natural products with promising nutritional regimens that standardize the amount of specific naturally occurring nutritional compounds (e.g., omega-3 fatty acids, anthocyanidins, polyphenols) with compelling preliminary evidence. The goal is to fund trials that can produce results of high scientific utility, whether positive or negative, to inform further development or testing decisions. The studies should replicate the impact of the natural product on target engagement in humans and assess associations between impact levels and functional or clinical outcomes in patients. The NOFO encourages designs that optimize the product's impact on target engagement through various doses or formulations, combine the product with other treatment approaches, or focus on target populations that are more responsive. The clinical trials must be hypothesis-driven, milestone-driven, and directly related to the research priorities and mission of the funding organization. Up to 3 years of support is available under this R33 funding mechanism to accelerate the clinical testing of promising natural products.