Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality… (NCT05912309) | Clinical Trial Compass
UnknownNot Applicable
Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity
Spain78 participantsStarted 2023-09-01
Plain-language summary
The goal of this randomized controlled trial\] is to investigate the effects of a 12-week time restricted eating (TRE) and exercise combined intervention, as compared to (i) TRE alone, and to (ii) Caloric Restriction (CR) plus the same exercise intervention elicited by the TRE group, on Skeletal muscle tissue (SMT) quantity, quality and function (primary outcome), Resting energy expenditure (REE) and cardiometabolic health (secondary outcomes), and miRNA biomarkers in postmenopausal women with overweight or obesity.
Who can participate
Age range
50 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:
* Age between 50 and 65 years.
* Menopause (Phase +1a)
* Body mass index ≥25.0 and \<40 kg/m2 or waist circumference \> 94 cm.
* Weight stability (within 3% of screening weight) for \>3 months prior to baseline.
* Sedentary lifestyle (\<150 min/week of moderate-vigorous intensity exercise) for \>3 months prior to baseline.
* Usual feeding window ≥12 hours.
Exclusion Criteria:
* History of major adverse cardiovascular events, clinically significant renal, endocrine or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer or other medical condition in which fasting or exercise is contraindicated.
* Use of exogenous (sex) hormones (hormone replacement therapy).
* Type 1 or type 2 diabetes.
* Severe psychiatric disorders, eating disorders, sleep disorders or alcohol abuse.
* Regular use of medications or compounds that may affect study results.
* Participating in a weight loss or weight control program.
* Caregiver of a dependent person who requires frequent nighttime care/sleep interruptions. Shift workers with variable schedules (e.g., nighttime). Frequent travel across time zones during the study period.
* Fear of needles and claustrophobia of magnetic resonance imaging (MRI).
* Any medical situation that prevents the performance of MRI (pacemakers, prostheses, etc).
* Being unable to understand and accept the instructions or the objectives and protocol of the study.
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
Skeletal muscle tissue quantity - Baseline
Timeframe: Just after the end of the 12-week intervention (+1 to +3 days)
2
Skeletal muscle tissue quantity - 12 weeks
Timeframe: Just before the start of the 12-week intervention (-3 to -1 days), just after the end of the 12-week intervention (+1 to +3 days) and 1 year after the end of the intervention
3
Skeletal muscle tissue quantity - 1 year
Timeframe: 1 year after the end of the intervention
4
Skeletal muscle tissue quality - Baseline
Timeframe: Just before the start of the 12-week intervention (-3 to -1 days)
5
Skeletal muscle tissue quality - 12 weeks
Timeframe: Just after the end of the 12-week intervention (+1 to +3 days)
6
Skeletal muscle tissue quality - 1 Year
Timeframe: 1 year after the end of the intervention