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Recruiting NCT05912309

Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity

Trial Parameters

Condition Menopause Related Conditions
Sponsor Idoia Labayen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 78
Sex FEMALE
Min Age 50 Years
Max Age 65 Years
Start Date 2023-09-01
Completion 2024-12
Interventions
Time Restricted Eating (TRE)ExerciseCaloric Restriction

Brief 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.

Eligibility 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

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