Time-restricted eating for postmenopausal women with metabolic issues
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
This study is testing if eating all meals within a 10-hour window can improve metabolic health in postmenopausal women who have metabolic issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04893226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of time-restricted feeding (TRF) on metabolic health in postmenopausal women who are metabolically unhealthy. Participants will be randomly assigned to either a TRF group, where they will consume all their daily calories within a 10-hour window, or a control group with no dietary restrictions. The study will last for 18 weeks, during which various metabolic parameters, including insulin sensitivity and body composition, will be measured. Data collection will include baseline assessments followed by monitoring of eating patterns and metabolic changes throughout the intervention period.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45-65 who are prediabetic or exhibit at least two features of metabolic syndrome.
Not a fit: Patients with diabetes, significant heart disease, or those on hormone therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve metabolic health and reduce the risk of conditions like diabetes and heart disease in postmenopausal women.
How similar studies have performed: Previous studies on time-restricted feeding have shown promising results in improving metabolic health, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Julie S Pendergast, PhD — University of Kentucky
- Study coordinator: Matt Thomas, PhD
- Email: jmthomg@uky.edu
- Phone: (859) 218-6770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.