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This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.
Age
45 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
University of Kentucky
Lexington, Kentucky, United States
Start Date
October 19, 2021
Primary Completion Date
January 31, 2027
Completion Date
January 31, 2027
Last Updated
November 19, 2025
164
ESTIMATED participants
Time-Restricted Feeding (TRF)
BEHAVIORAL
Lead Sponsor
Julie Pendergast
Collaborators
NCT07237750
NCT07460856
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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