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

Launched by IDOIA LABAYEN · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a combined approach of time-restricted eating (TRE) and exercise on muscle health in postmenopausal women who are overweight or obese. The study will last for 12 weeks and will compare three different groups: one group will follow the TRE and exercise plan, another group will only do TRE, and the third group will follow a traditional caloric restriction diet along with the same exercise. The main goal is to see how these methods affect muscle mass, quality, and function, as well as energy use and overall health.

To be eligible for this trial, participants should be women aged 50 to 65, who have gone through menopause, and have a body mass index (BMI) of 25 or higher. They should also have been living a sedentary lifestyle, meaning they haven’t been exercising much for the past three months. Participants can expect to follow a structured eating and exercise plan, and they will be monitored throughout the study. It’s important to note that certain health conditions and medications may prevent someone from participating, so a thorough screening will take place before enrollment.

Gender

FEMALE

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 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.