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)

Purpose: The effects of a variety of dietary interventions on aging-related outcomes have been examined in human and animal studies. Caloric restriction (CR) has long been known to extend life span and delay onset of a variety of age-related conditions in many, but not all, animal models. A randomized controlled clinical trial, Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE), in non-obese adults age 51 and under, showed favorable effects of two years of CR on risk factors for aging-related conditions and effects on mechanisms that may influence health span and longevity. However, there remains significant uncertainty about the feasibility of sustaining a longer-term CR intervention (e.g., five years or longer) and about whether the effects of CR, including rates of physiologic aging changes and pre-morbid disease progression, would be amplified or attenuated with the increased duration of CR. The findings of such a longer-term CR trial would be valuable whether or not CR is found to be feasible for a large segment of the population, since they would provide data on the relationship of CR effects on longer-term outcomes to mechanisms that could potentially be targeted by pharmacologic or other strategies.
Receipt Date: Expires: October 1, 2020
Total Awards: NIA intends to commit up to $1.85 million in FY 2021 to fund up to two awards.

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)


  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession


  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions
  • Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
  • Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
  • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.