<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/NCT03270475</url>
  </required_header>
  <id_info>
    <org_study_id>ACE</org_study_id>
    <nct_id>NCT03270475</nct_id>
  </id_info>
  <brief_title>Effect of Exercise on Muscle Proteome Signature</brief_title>
  <official_title>Effect of Exercise Training on Skeletal Muscle Proteome Signature of Young Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Morten Hostrup, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of the study is to investigate skeletal muscle proteome signature changes induced by&#xD;
      exercise training in young men&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Advances in omics technologies have allowed for the identification of biomarkers with&#xD;
      importance for the beneficial adaptations imposed by exercise training. Skeletal muscle&#xD;
      exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations&#xD;
      to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent&#xD;
      advances that have helped describe the proteomic landscape in response to a period of&#xD;
      exercise training, our understanding of the processes pertaining to post-translation&#xD;
      modification is scant. In this study, we aim to investigate the human acetylome and proteome&#xD;
      in response to exercise training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">October 15, 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal muscle proteome signature</measure>
    <time_frame>Change from baseline proteome signature at 5 weeks</time_frame>
    <description>proteomics</description>
  </primary_outcome>
  <other_outcome>
    <measure>Skeletal muscle acetylome signature</measure>
    <time_frame>Change from baseline acetylome signature at 5 weeks</time_frame>
    <description>acetylomics</description>
  </other_outcome>
  <other_outcome>
    <measure>Skeletal muscle mitochondrial respiration</measure>
    <time_frame>Change from baseline at 5 weeks</time_frame>
    <description>Mitochondrial respiratory capacity</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximal oxygen uptake</measure>
    <time_frame>Change from baseline at 5 weeks</time_frame>
    <description>Maximal oxygen uptake</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-15 training sessions of 30 min over 4-5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise training</intervention_name>
    <description>subjects complete 4-5 weeks of training</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  VO2max of 45-55 ml/kg/min (+/- SD) / 3000-4000 ml/min (+/- SD)&#xD;
&#xD;
          -  Body mass index (BMI) of 19-26 kg/m2&#xD;
&#xD;
          -  Normal ECG (electrocardiography)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious adverse effects to exercise&#xD;
&#xD;
          -  Chronic disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Morten Hostrup, PhD</investigator_full_name>
    <investigator_title>Assistant Professor, PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03270475
org study id: ACE
nct id: NCT03270475
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate skeletal muscle proteome signature changes induced by
      exercise training in young men
Advances in omics technologies have allowed for the identification of biomarkers with
      importance for the beneficial adaptations imposed by exercise training. Skeletal muscle
      exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations
      to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent
      advances that have helped describe the proteomic landscape in response to a period of
      exercise training, our understanding of the processes pertaining to post-translation
      modification is scant. In this study, we aim to investigate the human acetylome and proteome
      in response to exercise training.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Skeletal muscle proteome signature
time frame: Change from baseline proteome signature at 5 weeks
description: proteomics
measure: Skeletal muscle acetylome signature
time frame: Change from baseline acetylome signature at 5 weeks
description: acetylomics
measure: Skeletal muscle mitochondrial respiration
time frame: Change from baseline at 5 weeks
description: Mitochondrial respiratory capacity
measure: Maximal oxygen uptake
time frame: Change from baseline at 5 weeks
description: Maximal oxygen uptake
arm group label: Exercise
arm group type: Experimental
description: 12-15 training sessions of 30 min over 4-5 weeks
intervention type: Other
intervention name: exercise training
description: subjects complete 4-5 weeks of training
arm group label: Exercise
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Morten Hostrup, PhD
investigator title: Assistant Professor, PhD
sharing ipd: Undecided