Exercise TrainingNCT04460040
Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training
A study testing Exercise training in people with Exercise Training, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Mar 2021to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight [body mass index (BMI) 25-30
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Exercise training
- Keywords
- Metabolic adaptation, Energy expenditure, Exercise, Muscle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
A cycling ergometer with a varied workload will be used to assess muscle metabolic efficiency
Measured: 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 .
Changes in overnight sleeping metabolic rate will be evaluated by whole human room indirect calorimetry ("metabolic chamber")
Measured: 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.
Changes in diet induced thermogenesis will be evaluated 4 hours post breakfast by whole human room indirect calorimetry ("metabolic chamber")
Measured: Pre- and post 12 weeks of exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start27 Mar 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Gepner Yftach, Tel Aviv University
- Investigators
- Yftach Gepner, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460040
- Sponsor's protocol ID
- Metabolism
- Status last verified
- Feb 2024
- First submitted
- 29 Jun 2020
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Av EZ, Greenberg A, Knaan T, Melanson EL, Youngster I, Dubnov-Raz G, Borenstein E, Gepner Y. The associations between physical activity, microbiome and metabolic adaptation in sedentary overweight adults. Front Nutr. 2026 Feb 2;12:1722274. doi: 10.3389/fnut.2025.1722274. eCollection 2025.
PubMed 41704904
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training
- ClinicalTrials.gov ID
- NCT04460040
- Acronym / sponsor ID
- Metabolism
- Conditions
- Exercise Training
- Keywords
- Metabolic adaptation, Energy expenditure, Exercise, Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exercise trainingExercise 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight [body mass index (BMI) 25-30
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingThe 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. | Behavioural | Intervention |
Primary outcome
To examine long-term changes in the volume of highly metabolic organs (brain, liver, and kidneys) as an adaptive metabolic response to exercise training
Time frame: Pre- and post 12 weeks of exercise intervention
The volume of various organs will be measured using magnetic resonance imaging (MRI).
3 secondary outcomes
To evaluate the changes in skeletal muscle metabolic efficiency during non- exercise physical activity as an adaptive response to long-term exercise training
Time frame: 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 .
Time frame: 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.
Time frame: Pre- and post 12 weeks of exercise intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41704904Av EZ, Greenberg A, Knaan T, Melanson EL, Youngster I, Dubnov-Raz G, Borenstein E, Gepner Y. The associations between physical activity, microbiome and metabolic adaptation in sedentary overweight adults. Front Nutr. 2026 Feb 2;12:1722274. doi: 10.3389/fnut.2025.1722274. eCollection 2025.
Related trials for Exercise Training
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yftach Gepner, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Exercise Training, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Pre- and post 12 weeks of exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.