Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Conditions
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Metabolic Syndrome, Postmenopausal Symptoms

Intervention / Treatment
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* Behavioral: Time-Restricted Feeding (TRF)


Participation Criteria
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Eligibility Criteria
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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 sleep disorder extreme early or late chronotypes significant psychiatric disorders or ADHD diagnosed dysregulated eating behaviors

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopause, weight, metabolic risk, glucose, body composition, lipid, sleep, prediabetes, fasting, circadian, inflammation