Opportunity Information: Apply for RFA AG 21 016
This grant opportunity, RFA-AG-21-016, comes from the Department of Health and Human Services through the National Institutes of Health and supports cooperative agreement awards (U01). It is focused on setting up the groundwork for large, long-duration clinical trials that test whether sustained reductions in caloric intake and other structured dietary approaches can meaningfully influence aging-related risk factors and biological mechanisms tied to health span and longevity. Rather than funding the full multi-year intervention trial itself, the FOA funds a 3-year planning project designed to produce a trial-ready protocol and the operational infrastructure needed to run a much longer study (for example, a 5-year intervention).
The scientific goal is to plan clinical trials in one of two broad adult age bands: a younger cohort (ages 25 to 50) or an older cohort (50 years of age and above). Applicants are allowed to propose narrower ranges within those brackets if there is a strong rationale, such as targeting a window where adherence is more feasible or where specific aging-related risk trajectories are most informative. The planned trials are expected to evaluate sustained caloric restriction (CR) and compare it against both a control condition and at least one additional dietary intervention that changes the level, timing, or composition of nutrient intake. In practical terms, that means the future trial must have a minimum of three arms: (1) a control group, (2) a caloric restriction group, and (3) at least one other nutrition strategy, which could include approaches like time-restricted eating, alternate-day fasting patterns, macronutrient composition shifts, protein modulation, or other well-justified dietary modifications. The emphasis is on interventions that are feasible to maintain over years and that can be delivered with enough structure to make comparisons scientifically credible.
Because these are planning awards, the deliverables center on designing a rigorous, implementable trial. The FOA highlights core planning needs such as defining and refining the interventions (including dosing, intensity, delivery format, and behavioral supports), establishing recruitment strategies and realistic enrollment targets, setting eligibility and exclusion criteria, and selecting outcomes that are pre-specified and measurable in a standardized way. A major theme is adherence: applicants are expected to plan behavioral intervention components that help participants achieve and maintain the assigned eating pattern over long periods, and to specify how adherence will be measured objectively and consistently. The FOA also stresses outcome ascertainment and analysis planning, meaning applicants should think through how outcomes will be collected across sites (if multi-site), how data quality will be maintained, and what statistical approaches will be used to evaluate intervention effects and mechanistic pathways.
In addition to protocol and infrastructure planning, the award can support pilot studies and targeted data analyses that are necessary to make the eventual long-term trial realistic and well-powered. These pilots might be used to test recruitment channels, run-through intervention delivery and counseling workflows, assess adherence measurement tools, estimate variability in key biomarkers, or troubleshoot operational issues that tend to derail long studies. The intent is that by the end of the 3-year planning period, the team has the evidence, procedures, and finalized design elements needed to launch a definitive long-duration trial capable of answering whether sustained caloric restriction or other dietary pattern changes affect aging-related risk factors and mechanisms linked to healthier aging.
From an administrative standpoint, this is a discretionary health funding opportunity under CFDA 93.866, using a cooperative agreement mechanism, which typically implies substantial NIH program involvement during the project. The FOA listed an expected number of awards of 2 and an award ceiling of $700,000. Eligibility is broad and includes state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; public housing authorities; a variety of nonprofit organizations (including 501(c)(3) and non-501(c)(3)); and for-profit entities including small businesses, along with other organizations as described in the additional eligibility language. The opportunity was created on February 24, 2020, with an original closing date of July 23, 2020.
Overall, the program is aimed at moving the field toward well-designed, long-term, randomized dietary intervention trials that go beyond short-term weight or metabolic endpoints and instead focus on sustained dietary change as a tool to influence the biology of aging and downstream risk for aging-associated conditions. The planning awards are meant to reduce uncertainty and execution risk by forcing careful up-front work on intervention choice, participant selection, adherence strategy, outcome selection, measurement, and analysis so that a subsequent full-scale trial has a strong chance of being both feasible and scientifically decisive.Apply for RFA AG 21 016
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning Projects for Clinical Trials on Effects of Sustained Reductions in Caloric Intake and Related Dietary Practices in Younger and Older Persons (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on Feb 24, 2020.
- Applicants must submit their applications by Jul 23, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $700,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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