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

NCT04460040 | Active Not Recruiting

• 1 other identifier: Metabolism
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Exercise Training

Keywords

Metabolic adaptation; Energy expenditure; Exercise; Muscle

Outcome Measures

Primary Outcomes (1)

• To examine long-term changes in the volume of highly metabolic organs (brain, liver, and kidneys) as an adaptive metabolic response to exercise training

  The volume of various organs will be measured using magnetic resonance imaging (MRI).

  Pre- and post 12 weeks of exercise intervention

Secondary Outcomes (3)

• To evaluate the changes in skeletal muscle metabolic efficiency during non- exercise physical activity as an adaptive response to long-term exercise training

  Pre- and post 12 weeks of exercise intervention

• To determine the effect of long-term exercise training on changes in sleeping metabolic rate as an adaptive response .

  Pre- and post 12 weeks of exercise intervention

• To assess the effect of long-term exercise training on changes in diet induced thermogenesis as an adaptive response.

  Pre- and post 12 weeks of exercise intervention

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Exercise training

Interventions

Exercise training 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.

Intervention

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight \[body mass index (BMI) 25-30

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, Other, 6997801, Israel

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yftach Gepner, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: March 27, 2021
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

IL (1)