<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460040</url>
  </required_header>
  <id_info>
    <org_study_id>Matabolism</org_study_id>
    <nct_id>NCT04460040</nct_id>
  </id_info>
  <brief_title>Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training</brief_title>
  <official_title>Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel Aviv University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this proposal is to identify changes in the volume of highly metabolic&#xD;
      organs (liver, kidneys, and brain) that occur as a physiological adaptation to exercise&#xD;
      training and lower the resting energy expenditure. Secondary aims are to identify changes in&#xD;
      the metabolic efficiency of muscle in low levels of physical activity and evaluate the&#xD;
      effects on components of total daily energy expenditure including the sleeping metabolic rate&#xD;
      (SMR) and diet induced thermogenesis (DIT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a clinical trial type protocol, 16 overweight (body mass index: 25-30 kg/m2) men (n=8)&#xD;
      and women (n=8) aged 21 to 45 years will exercise for 3 months in a moderate intensity&#xD;
      regimen of 20 kcal/week/kg body weight that reflects current recommendations for weight&#xD;
      management. The volume of various organs will be measured pre- and post-exercise intervention&#xD;
      using magnetic resonance imaging (MRI). A cycling ergometer with a varied workload will be&#xD;
      used to assess muscle metabolic efficiency. Changes in overnight SMR and 4 hours post&#xD;
      breakfast DIT will be evaluated by whole human room indirect calorimetry (&quot;metabolic&#xD;
      chamber&quot;). In addition, free-living Total Energy Expenditure (TEE) will be measured for ten&#xD;
      days pre- and post-intervention by doubly labeled water.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 27, 2021</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>Pre- and post 12 weeks of exercise intervention</time_frame>
    <description>The volume of various organs will be measured using magnetic resonance imaging (MRI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the changes in skeletal muscle metabolic efficiency during non- exercise physical activity as an adaptive response to long-term exercise training</measure>
    <time_frame>Pre- and post 12 weeks of exercise intervention</time_frame>
    <description>A cycling ergometer with a varied workload will be used to assess muscle metabolic efficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of long-term exercise training on changes in sleeping metabolic rate as an adaptive response .</measure>
    <time_frame>Pre- and post 12 weeks of exercise intervention</time_frame>
    <description>Changes in overnight sleeping metabolic rate will be evaluated by whole human room indirect calorimetry (&quot;metabolic chamber&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of long-term exercise training on changes in diet induced thermogenesis as an adaptive response.</measure>
    <time_frame>Pre- and post 12 weeks of exercise intervention</time_frame>
    <description>Changes in diet induced thermogenesis will be evaluated 4 hours post breakfast by whole human room indirect calorimetry (&quot;metabolic chamber&quot;)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Exercise Training</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Overweight [body mass index (BMI) 25-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another exercise or weight loss program in the last 6 months&#xD;
&#xD;
          -  Non-stable weight (&gt;±5%) over the past 6 months&#xD;
&#xD;
          -  Current regular exercise &gt; 1 hour per week&#xD;
&#xD;
          -  Smoking within the past 6 months&#xD;
&#xD;
          -  Being post-menopausal, breastfeeding, pregnancy, or having been pregnant within the&#xD;
             past 6 months&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
&#xD;
          -  Cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)&#xD;
&#xD;
          -  Musculoskeletal or neuromuscular impairments that preclude exercise training&#xD;
&#xD;
          -  Having other health issues include cancer, diabetes, thyroid disease, hypertension,&#xD;
             chronic renal failure, cognitive impairments&#xD;
&#xD;
          -  Use of drugs that potentially impact body metabolism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yftach Gepner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tel Aviv University</name>
      <address>
        <city>Tel Aviv</city>
        <state>Other</state>
        <zip>6997801</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Gepner Yftach</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Metabolic adaptation</keyword>
  <keyword>Energy expenditure</keyword>
  <keyword>Exercise</keyword>
  <keyword>Muscle</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460040
org study id: Matabolism
nct id: NCT04460040
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: N/A
intervention model: Single Group Assignment
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
masking: None (Open Label)
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
description: The volume of various organs will be measured using magnetic resonance imaging (MRI).
measure: 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
description: A cycling ergometer with a varied workload will be used to assess muscle metabolic efficiency
measure: 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
description: Changes in overnight sleeping metabolic rate will be evaluated by whole human room indirect calorimetry ("metabolic chamber")
measure: 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
description: Changes in diet induced thermogenesis will be evaluated 4 hours post breakfast by whole human room indirect calorimetry ("metabolic chamber")
arm group label: Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Exercise training
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yftach Gepner, PhD
role: Principal Investigator
affiliation: Tel Aviv University
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Gepner Yftach
investigator title: Principal investigator