Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Sponsor

Julie Pendergast (Other)

Overall Status

Recruiting

CT.gov ID

NCT04893226

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

164

Enrollment

Location

Arms

52.3

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Postmenopausal Symptoms	Behavioral: Time-Restricted Feeding (TRF)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Feb 27, 2026

Anticipated Study Completion Date :

Feb 27, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.
Experimental: Time-Restricted Feeding (TRF) Group Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.	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.

Arm

Intervention/Treatment

No Intervention: Control

Experimental: Time-Restricted Feeding (TRF) Group

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.

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.

Outcome Measures

Primary Outcome Measures

Change in Insulin Sensitivity [18 weeks (baseline and post-intervention)]
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Change in Body Mass Index [18 weeks (baseline and post-intervention)]
Body mass index will be calculated from height and weight.
Change in Triglycerides [18 weeks (baseline and post-intervention)]
Triglycerides will be measured from fasting blood

Secondary Outcome Measures

Change in Hemoglobin A1c [18 weeks (baseline and post-intervention)]
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Change in C-Reactive Protein [18 weeks (baseline and post-intervention)]
CRP will be measured from blood samples.
Change in Mid-sleep [18 weeks (baseline and post-intervention)]
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Change in Sleep Fragmentation Index [18 weeks (baseline and post-intervention)]
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.