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

RECRUITINGN/ASponsored by Idoia Labayen
Actively Recruiting
PhaseN/A
SponsorIdoia Labayen
Started2023-09-01
Est. completion2024-12
Eligibility
Age50 Years – 65 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 50 Years – 65 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions5

Liver DiseaseMenopause Related ConditionsObesityOsteoporosis, PostmenopausalSarcopenia

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