Clinical trial NCT04460040: Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training
Official title: Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise Training
Keywords: Metabolic adaptation
Energy expenditure
Exercise
Muscle
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2020-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: To examine long-term changes in the volume of highly metabolic organs (brain, liver, and kidneys) as an adaptive metabolic response to exercise training
timeFrame: Pre- and post 12 weeks of exercise intervention
Secondary outcomes:
measure: To evaluate the changes in skeletal muscle metabolic efficiency during non- exercise physical activity as an adaptive response to long-term exercise training
timeFrame: Pre- and post 12 weeks of exercise intervention
measure: To determine the effect of long-term exercise training on changes in sleeping metabolic rate as an adaptive response .
timeFrame: Pre- and post 12 weeks of exercise intervention
measure: To assess the effect of long-term exercise training on changes in diet induced thermogenesis as an adaptive response.
timeFrame: Pre- and post 12 weeks of exercise intervention
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
state: Other
Study officials:
affiliation: Tel Aviv University
name: Yftach Gepner, PhD
role: PRINCIPAL_INVESTIGATOR
References: