Circadian Rhythms in Postmenopausal Women (NCT04893226) | Clinical Trial Compass
RecruitingNot Applicable
Circadian Rhythms in Postmenopausal Women
United States164 participantsStarted 2021-10-19
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Insulin Sensitivity
Timeframe: 18 weeks (baseline and post-intervention)
2
Change in Body Mass Index
Timeframe: 18 weeks (baseline and post-intervention)
3
Change in Triglycerides
Timeframe: 18 weeks (baseline and post-intervention)