<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/NCT02222415</url>
  </required_header>
  <id_info>
    <org_study_id>MEC 11-03-45</org_study_id>
    <nct_id>NCT02222415</nct_id>
  </id_info>
  <brief_title>Exercise Training in Healthy Young Men</brief_title>
  <official_title>The Impact of Timed Protein Supplementation to Maximize the Skeletal Muscle Adaptive Response to Resistance Type Exercise Training in Healthy Young Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resistance type exercise training has been shown to be a potent stimulus to increase skeletal&#xD;
      muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to&#xD;
      affect the muscle adaptive response following exercise. Whether timed protein intake could&#xD;
      augment the increase in muscle fiber size and/or satellite cell content following long-term&#xD;
      exercise intervention remains to be established.&#xD;
&#xD;
      We hypothesize that protein supplementation before sleep, on both training and non-training&#xD;
      days, during a 12 week resistance training program further increases type II muscle fibre&#xD;
      cross sectional area when compared to the placebo group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal muscle fiber size</measure>
    <time_frame>12 weeks</time_frame>
    <description>Skeletal muscle fiber size will be assessed by muscle biopsy sampling before, during and after the 12 wks intervention period.&#xD;
Muscle fiber size will be expressed in µm2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quadriceps cross-sectional area</measure>
    <time_frame>12 weeks</time_frame>
    <description>Quadriceps cross-sectional area will be assessed by CT-scan before and after the 12 wks intervention period.&#xD;
Quadriceps cross-sectional area will be expressed in cm2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body en regional body composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body composition (whole-body as well as regional) well be determined by DXA-scan performed before and after the 12 wks intervention period.&#xD;
Results will be expressed in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1RM strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Maximum muscle strength will be assessed before, during and after 12 wks of exercise training by means of a 1 rep max test and will be expressed in kilograms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Gaining Skeletal Muscle Mass and Strength</condition>
  <arm_group>
    <arm_group_label>Training + placebo drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Exercise + non-caloric placebo drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise + Protein drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercise + Drink containing Protein, Carbohydrates and Fat</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Exercise + Protein drink</intervention_name>
    <arm_group_label>Exercise + Protein drink</arm_group_label>
    <arm_group_label>Training + placebo drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Age between 18 and 30 years&#xD;
&#xD;
          -  BMI between 18.5 and 30 kg/m2&#xD;
&#xD;
          -  Recreationally active, performing sports on a non-competitive basis between 2 and 5&#xD;
             hours p/wk&#xD;
&#xD;
          -  Participants willing and able to give written informed consent and to understand, to&#xD;
             participate and to comply with the biomedical research project requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HbA1C level above 6.5%&#xD;
&#xD;
          -  Fasted blood glucose level above 7 mmol/L&#xD;
&#xD;
          -  Serum creatinine level beneath 60 or above 120 µmol/L&#xD;
&#xD;
          -  Participants with a recent history or current state of COPD&#xD;
&#xD;
          -  Participants with a recent history or current state of rheumatoid arthritis&#xD;
&#xD;
          -  Participants with a recent history or current state of musculoskeletal/orthopedic&#xD;
             disorders&#xD;
&#xD;
          -  Participants with a recent history or current state of renal disorder&#xD;
&#xD;
          -  Participants with a recent history or current state of cognitive impairment&#xD;
&#xD;
          -  Participants with orthopedic metal implants in the spine and/or upper/lower&#xD;
             extremities&#xD;
&#xD;
          -  Participants with lactose intolerance and/or dairy protein allergy&#xD;
&#xD;
          -  Participants who are enrolled in an interventional biomedical research project or have&#xD;
             received an investigational new drug or product with the last 30 days prior to&#xD;
             screening.&#xD;
&#xD;
          -  Participants on medication, including anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229ER</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.</citation>
    <PMID>23134885</PMID>
  </reference>
  <reference>
    <citation>Res PT, Groen B, Pennings B, Beelen M, Wallis GA, Gijsen AP, Senden JM, VAN Loon LJ. Protein ingestion before sleep improves postexercise overnight recovery. Med Sci Sports Exerc. 2012 Aug;44(8):1560-9. doi: 10.1249/MSS.0b013e31824cc363.</citation>
    <PMID>22330017</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Muscle mass</keyword>
  <keyword>Strength</keyword>
  <keyword>Cross-sectional area</keyword>
  <keyword>Protein</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/NCT02222415
org study id: MEC 11-03-45
nct id: NCT02222415
lead sponsor: 
has dmc: Yes
Resistance type exercise training has been shown to be a potent stimulus to increase skeletal
      muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to
      affect the muscle adaptive response following exercise. Whether timed protein intake could
      augment the increase in muscle fiber size and/or satellite cell content following long-term
      exercise intervention remains to be established.

      We hypothesize that protein supplementation before sleep, on both training and non-training
      days, during a 12 week resistance training program further increases type II muscle fibre
      cross sectional area when compared to the placebo group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Skeletal muscle fiber size
time frame: 12 weeks
description: Skeletal muscle fiber size will be assessed by muscle biopsy sampling before, during and after the 12 wks intervention period.
Muscle fiber size will be expressed in µm2
measure: Quadriceps cross-sectional area
time frame: 12 weeks
description: Quadriceps cross-sectional area will be assessed by CT-scan before and after the 12 wks intervention period.
Quadriceps cross-sectional area will be expressed in cm2
measure: Whole body en regional body composition
time frame: 12 weeks
description: Body composition (whole-body as well as regional) well be determined by DXA-scan performed before and after the 12 wks intervention period.
Results will be expressed in kilograms
measure: 1RM strength
time frame: 12 weeks
description: Maximum muscle strength will be assessed before, during and after 12 wks of exercise training by means of a 1 rep max test and will be expressed in kilograms.
arm group label: Training + placebo drink
arm group type: Placebo Comparator
description: Exercise + non-caloric placebo drink
arm group label: Exercise + Protein drink
arm group type: Experimental
description: exercise + Drink containing Protein, Carbohydrates and Fat
intervention type: Dietary Supplement
intervention name: Exercise + Protein drink
arm group label: Exercise + Protein drink
arm group label: Training + placebo drink
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
citation: Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
PMID: 23134885
citation: Res PT, Groen B, Pennings B, Beelen M, Wallis GA, Gijsen AP, Senden JM, VAN Loon LJ. Protein ingestion before sleep improves postexercise overnight recovery. Med Sci Sports Exerc. 2012 Aug;44(8):1560-9. doi: 10.1249/MSS.0b013e31824cc363.
PMID: 22330017
responsible party type: Sponsor