Effects of time-restricted eating and exercise on muscle health in postmenopausal women with obesity
Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity
This study is testing if combining time-restricted eating with exercise can improve muscle health in postmenopausal women who are overweight or obese.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | Female |
| Sponsor | Universidad Pública de Navarra Academic / other |
| Locations | 1 site (Pamplona, Navarra) |
| Trial ID | NCT05912309 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a 12-week intervention combining time-restricted eating (TRE) and exercise on skeletal muscle mass, quality, and function in postmenopausal women who are overweight or obese. Participants will be randomly assigned to one of three groups: TRE with exercise, TRE alone, or caloric restriction with exercise. The study aims to measure primary outcomes related to skeletal muscle tissue and secondary outcomes including resting energy expenditure and cardiometabolic health. The trial also seeks to explore the underlying mechanisms of muscle health in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 50 to 65 years with a body mass index between 25 and 40 who lead a sedentary lifestyle.
Not a fit: Patients with significant medical conditions, such as diabetes or severe psychiatric disorders, or those on hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective lifestyle interventions for improving muscle health and managing obesity in postmenopausal women.
How similar studies have performed: While studies on time-restricted eating have shown promise in other populations, this specific approach in postmenopausal women at risk of sarcopenia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pamplona, Navarra
- Universidad Pública de Navarra — Pamplona, Navarra, Spain (Recruiting)
Study contacts
- Principal investigator: Idoia Labayen, PhD — Universidad Pública de Navarra
- Study coordinator: Idoia Labayen, PhD
- Email: idoia.labayen@unavarra.es
- Phone: 644699839
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.