NCT04893226

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Julie Pendergast · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Metabolic Syndrome
• Postmenopausal Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Time-Restricted Feeding (TRF)	Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.

Timeline

• Start date: 2021-10-19
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2021-05-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States