RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Time Restricted Eating (TRE)

Participants will be required to reduce their eating time window to ≤ 8 hours/day. Women can choose when to begin eating, but the last meal should be completed before or at 20:00 hours (concentrating the eating window towards the active phase confers higher cardiometabolic health benefits). Our preliminary results suggest that this eating window is feasible and safe. Participants will receive dietary advice regarding the daily amount of high quality protein and meal-specific protein quantities. All the participants will attend a lifestyle education program based on Mediterranean diet and WHO physical activity recommendations every two weeks.

BEHAVIORAL

Exercise

Sport sciences specialists will design, supervise and monitor the concurrent exercise intervention following the 2020 WHO recommendations. The program will be tailored to the participant's ability and health, and will be focused on a gradual increase to levels that are safe. Resistance training: 3 times/week designed to manage, attenuate and even prevent the loss of skeletal muscle tissue and function. The exercise sessions will be scheduled within or immediately after their eating window in order to maximize muscular muscle protein synthesis. Morning and afternoon training schedules will be offered to participants.

BEHAVIORAL

Caloric Restriction

Individualised intensive behavioural intervention weight loss program including CR, exercise training and lifestyle education designed according to the current guidelines. CR will be tailored to participants (objectively assessed). Diet will provide 600 kcal/day less than the individual energy requirements based on measured resting energy expenditure (indirect calorimetry) and multiplied by an activity factor obtained by accelerometry. Experienced nutritionists will design personalized and balanced CR diet, and will train the participants through the food exchange system to follow the treatment. In those cases in which the CR compromised a protein intake of at least 1.2 g/kg/day, the macronutrient percentage distribution will be modified prioritizing achieving this minimum protein intake.

Locations (1)

Universidad Pública de Navarra

Pamplona, Navarre, Spain