Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Postmenopausal Symptoms
• Interventions: Behavioral: Time-Restricted Feeding (TRF)

• Registration Number: NCT04893226
• Lead Sponsor: Julie Pendergast

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.

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 Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-19
• Study Start: 2021-10-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

• postmenopausal women
• age 45-65 years
• prediabetic or have at least 2 features of metabolic syndrome

Exclusion Criteria

• on hormone therapy
• diabetes
• heart disease
• alcohol consumption of >2 drinks per day
• significant circadian disruption
• having care-taking responsibilities that significantly affect sleep
• shift work or irregular lifestyle
• uncontrolled sleep apnea or other uncontrolled sleep disorder
• extreme early or late chronotypes
• significant psychiatric disorders
• taking ADHD medications
• diagnosed dysregulated eating behaviors
• smoking >5 cigarettes/day or 30 pack-year history
• participating in formal weight loss program
• not weight stable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time-Restricted Feeding (TRF) Group	Time-Restricted Feeding (TRF)	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.

Primary Outcome Measures

Name	Time	Method
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
Change in Insulin Sensitivity	18 weeks (baseline and post-intervention)	Matsuda index will be assessed by the oral glucose tolerance test (OGTT).

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	18 weeks (baseline and post-intervention)	HbA1c is a measure of the proportion of glycated hemoglobin in blood.
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 C-Reactive Protein	18 weeks (baseline and post-intervention)	CRP will be measured from blood samples.
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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States