Health, Aging and Later-Life Outcomes

NCT05424042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-10-27

Study results available
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Summary

The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.

Conditions

  • Aging

Interventions

BEHAVIORAL

In-Person Caloric Restriction

20% CR delivered in-person by dietitian/coach

BEHAVIORAL

Remote Caloric Restriction

20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.

BEHAVIORAL

Time-restricted

8-hour TRE with ad libitum caloric intake. This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stephen B. Kritchevsky, PhD · Wake Forest University Health Sciences

  • Barbara J. Nicklas, PhD · Wake Forest University Health Sciences

  • Michael E. Miller, PhD · Wake Forest University Health Sciences

  • W. Jack Rejeski, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2024-07-22
Completion
2024-07-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05424042 on ClinicalTrials.gov