Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Julie Pendergast
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Julie Pendergast
Assistant Professor
University of Kentucky
Eligibility Criteria
Inclusion Criteria
- •postmenopausal women
- •age 45-65 years
- •prediabetic or have at least 2 features of metabolic syndrome
Exclusion Criteria
- •on hormone therapy
- •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
Outcomes
Primary Outcomes
Change in Body Mass Index
Time Frame: 18 weeks (baseline and post-intervention)
Body mass index will be calculated from height and weight.
Change in Triglycerides
Time Frame: 18 weeks (baseline and post-intervention)
Triglycerides will be measured from fasting blood
Change in Insulin Sensitivity
Time Frame: 18 weeks (baseline and post-intervention)
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Secondary Outcomes
- Change in Hemoglobin A1c(18 weeks (baseline and post-intervention))
- Change in Mid-sleep(18 weeks (baseline and post-intervention))
- Change in C-Reactive Protein(18 weeks (baseline and post-intervention))
- Change in Sleep Fragmentation Index(18 weeks (baseline and post-intervention))