Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training

NCT ID: NCT04460040

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-27
• Study Completion Date: 2024-11-01

Brief Summary

The primary aim of this proposal is to identify changes in the volume of highly metabolic organs (liver, kidneys, and brain) that occur as a physiological adaptation to exercise training and lower the resting energy expenditure. Secondary aims are to identify changes in the metabolic efficiency of muscle in low levels of physical activity and evaluate the effects on components of total daily energy expenditure including the sleeping metabolic rate (SMR) and diet induced thermogenesis (DIT).

Detailed Description

Using a clinical trial type protocol, 16 overweight (body mass index: 25-30 kg/m2) men (n=8) and women (n=8) aged 21 to 45 years will exercise for 3 months in a moderate intensity regimen of 20 kcal/week/kg body weight that reflects current recommendations for weight management. The volume of various organs will be measured pre- and post-exercise intervention using magnetic resonance imaging (MRI). A cycling ergometer with a varied workload will be used to assess muscle metabolic efficiency. Changes in overnight SMR and 4 hours post breakfast DIT will be evaluated by whole human room indirect calorimetry ("metabolic chamber"). In addition, free-living Total Energy Expenditure (TEE) will be measured for ten days pre- and post-intervention by doubly labeled water.

Conditions

Exercise Training

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

Exercise in moderate intensity tailored individually to 20 kcal/kg/week (range 1500-2000 kcal/week) with a free choice to exercise at home/gym on a treadmill or outdoors.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

The first phase of the study will comprise two weeks of control phase when participants will not engage in any exercise training but will be monitored for total daily energy expenditure and its components (REE, SMR, and DIT) and assessed volume of metabolic organs and skeletal muscle efficiency.

Next, participants will start the active phase. In the first two weeks, participants will perform 150 - 200 min/week of a moderate intensity exercise so that they can adapt to the new regime and avoid injury. All exercise training will be monitored using heart rate sensor (HR) to track exercise adherence and HR range goals. Changes in daily non-exercise physical activity and sedentary behavior will be assessed for 10 days pre- and post-intervention by a tri-axial accelerometer. All study participants will be instructed to consume their habitual diet and to maintain the same caloric intake.

Interventions

Exercise training

The first phase of the study will comprise two weeks of control phase when participants will not engage in any exercise training but will be monitored for total daily energy expenditure and its components (REE, SMR, and DIT) and assessed volume of metabolic organs and skeletal muscle efficiency.

Next, participants will start the active phase. In the first two weeks, participants will perform 150 - 200 min/week of a moderate intensity exercise so that they can adapt to the new regime and avoid injury. All exercise training will be monitored using heart rate sensor (HR) to track exercise adherence and HR range goals. Changes in daily non-exercise physical activity and sedentary behavior will be assessed for 10 days pre- and post-intervention by a tri-axial accelerometer. All study participants will be instructed to consume their habitual diet and to maintain the same caloric intake.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Overweight [body mass index (BMI) 25-30

Exclusion Criteria

• Participation in another exercise or weight loss program in the last 6 months
• Non-stable weight (>±5%) over the past 6 months
• Current regular exercise > 1 hour per week
• Smoking within the past 6 months
• Being post-menopausal, breastfeeding, pregnancy, or having been pregnant within the past 6 months
• Previous bariatric surgery
• Cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)
• Musculoskeletal or neuromuscular impairments that preclude exercise training
• Having other health issues include cancer, diabetes, thyroid disease, hypertension, chronic renal failure, cognitive impairments
• Use of drugs that potentially impact body metabolism.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Gepner Yftach

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yftach Gepner, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Tel Aviv University

Tel Aviv, Other, Israel

Countries

Israel

Other Identifiers

Metabolism

Identifier Type: -

Identifier Source: org_study_id