OpportunityTitle: 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)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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.
Description: This funding opportunity announcement (FOA) invites applications for 3-year planning projects for trials in either of two age ranges (25 to 50 or ? 50 years of age) to determine the effects of sustained (e.g. 5-year) caloric restriction (CR) and other interventions that modify the amount, timing, or composition of nutrient intake on risk factors for aging-related conditions and mechanisms that may influence health span and longevity. Proposed projects must plan for trials with a minimum of three arms: a control group, a CR group, and at least one other nutritional intervention that modifies level, timing, or composition of nutrient intake. Narrower age ranges within the younger and older age groups may be proposed. The projects will support organizational, planning, and protocol development activities, addressing elements such as selection and design of interventions, recruitment, eligibility criteria, selection of pre-specified study outcomes, outcome ascertainment, behavioral interventions to achieve and maintain adherence, adherence measurement, and outcome analysis. The projects will also support pilot studies and data analyses needed for these planning activities.
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GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV