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

NCT05912309 | Recruiting

• 2 other identifiers: PI_2023/8EXP_75091
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause Related Conditions; Sarcopenia; Osteoporosis Postmenopausal; Obesity

Keywords

Obesity; Overweight; Sarcopenia; Menopause; Exercise; Resistance Exercise; Physical activity; intramuscular adipose tissue; Visceral adipose tissue; Liver fat; Skeletal muscle mass; Muscle function; Muscle quality; Osteoporosis

Outcome Measures

Primary Outcomes (15)

• Skeletal muscle tissue quantity - Baseline

  Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  Just after the end of the 12-week intervention (+1 to +3 days)

• Skeletal muscle tissue quantity - 12 weeks

  Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  Just before the start of the 12-week intervention (-3 to -1 days), just after the end of the 12-week intervention (+1 to +3 days) and 1 year after the end of the intervention

• Skeletal muscle tissue quantity - 1 year

  Skeletal muscle tissue (Cross sectional area (cm2) and Volume (cm3)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  1 year after the end of the intervention

• Skeletal muscle tissue quality - Baseline

  Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  Just before the start of the 12-week intervention (-3 to -1 days)

• Skeletal muscle tissue quality - 12 weeks

  Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  Just after the end of the 12-week intervention (+1 to +3 days)

• Skeletal muscle tissue quality - 1 Year

  Intermuscular and Intramuscular adipose tissue (fat fraction(%)) will be quantified by magnetic resonance imaging ((MRI) Magnetom Vida 3T system, Siemens, Healthineers), the gold standard methodology, at the most representative sites: mid-thigh, psoas (L3) and paraspinal and abdominal wall (L2-L4). Both Detailed information about imaging segmentation and processing can be found in previous work of our group. The segmentation for all these structures will be done with a semiautomatic proprietary algorithm developed in our group.

  1 year after the end of the intervention

• Lower Body Muscle function - Baseline

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  Just before the start of the 12-week intervention (-3 to -1 days)

• Lower Body Muscle function - 12 weeks

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  Just after the end of the 12-week intervention (+1 to +3 days)

• Lower Body Muscle function - 1 year

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  1 year after the end of the intervention

• Upper Body Muscle function - Baseline

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  Just before the start of the 12-week intervention (-3 to -1 days)

• Upper Body Muscle function - 12 weeks

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  Just after the end of the 12-week intervention (+1 to +3 days)

• Upper Body Muscle function - 1 year

  Muscle function will be determined using a linear position transducer (watios and m/s). 1-RM will be also estimated from this data.

  1 year after the end of the intervention

• Handgrip Strength - Baseline

  Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)

  Just before the start of the 12-week intervention (-3 to -1 days)

• Handgrip Strength - 12 weeks

  Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)

  Just after the end of the 12-week intervention (+1 to +3 days)

• Handgrip Strength - 1 year

  Handgrip strength will be determined by the handgrip strength test using a digital hand dynamometer (kilograms)

  1 year after the end of the intervention

Secondary Outcomes (19)

• Resting energy expenditure

  Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention

• Ectopic fat

  Just before the start of the 12-week intervention (-3 to -1 days), just after the end of the 12-week intervention (+1 to +3 days) and 1 year after the end of the intervention

• Bone Mineral Density

  Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention

• Lean Mass

  Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention

• Bone Mineral Content

  Just before the start of the 12-week intervention (-7 to -3 days), just after the end of the 12-week intervention (+3 to +7 days) and 1 year after the end of the intervention

Other Outcomes (7)

• Energy intake and macronutrient distribution

  Just before the start of the 12-week intervention (-7 to -3 days), every 2 weeks during the 12-week intervention, just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention

• Physical activity

  Just before the start of the 12-week intervention (-12 to -3 days), just after the end of the 12-week intervention (+3 to +12 days) and 1 year after the end of the intervention

• Adherence to lifestyle intervention

  Just before the start of the 12-week intervention (-7 to -3 days), every 2 weeks during the 12-week intervention, just after the end of the 12-week intervention (+3 to +7 days), and 1 year after the end of the intervention

Study Arms (3)

Time Restricted Eating (TRE)

EXPERIMENTAL

Behavioral: Time Restricted Eating (TRE)

Time Restricted Eating (TRE) + Exercise

EXPERIMENTAL

Behavioral: Time Restricted Eating (TRE); Behavioral: Exercise

Caloric restriction (CR) + Exercise

ACTIVE COMPARATOR

Behavioral: Exercise; Behavioral: Caloric Restriction

Interventions

Time Restricted Eating (TRE) BEHAVIORAL

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.

Time Restricted Eating (TRE); Time Restricted Eating (TRE) + Exercise

Exercise BEHAVIORAL

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.

Caloric restriction (CR) + Exercise; Time Restricted Eating (TRE) + Exercise

Caloric Restriction BEHAVIORAL

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.

Caloric restriction (CR) + Exercise

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idoia Labayen: lead
• Hospital of Navarra: collaborator

Study Sites (1)

Universidad Pública de Navarra

Pamplona, Navarre, 31006, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Osteoporosis, Postmenopausal; Obesity; Overweight; Motor Activity; Fatty Liver; Osteoporosis

Interventions

Exercise; Caloric Restriction

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Behavior; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Idoia Labayen, PhD

  Universidad Pública de Navarra

  PRINCIPAL INVESTIGATOR

• Estrella Petrina, PhD

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idoia Labayen, PhD

CONTACT

644699839; idoia.labayen@unavarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Randomized controlled parallel-arm clinical trial

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 22, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)