<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/NCT03797781</url>
  </required_header>
  <id_info>
    <org_study_id>6500619582</org_study_id>
    <nct_id>NCT03797781</nct_id>
  </id_info>
  <brief_title>Protein Ingestion and Skeletal Muscle Atrophy</brief_title>
  <official_title>Understanding the Role of Protein Ingestion on Skeletal Muscle Atrophy During an Acute Period of Disuse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</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 effect of different protein intakes on skeletal muscle atrophy during short term&#xD;
      unilateral leg immobilisation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle size</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Muscle Atrophy</condition>
  <arm_group>
    <arm_group_label>High protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Minimum protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower limb immobilisation (leg brace) with varying levels of protein intake</intervention_name>
    <description>Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake</description>
    <arm_group_label>High protein</arm_group_label>
    <arm_group_label>Low protein</arm_group_label>
    <arm_group_label>Minimum protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;18 and &lt;28 no prescription medications or current illness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;18 and &gt;28 current prescription medication no history of leg injury.&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic&#xD;
             disease ((e.g. type 2 diabetes)), any personal or family history of deep vein&#xD;
             thrombosis.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sport and Health Science</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT03797781
org study id: 6500619582
nct id: NCT03797781
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effect of different protein intakes on skeletal muscle atrophy during short term
      unilateral leg immobilisation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Muscle size
time frame: 3 days
measure: Muscle strength
time frame: 3 days
arm group label: High protein
arm group type: Experimental
arm group label: Low protein
arm group type: Experimental
arm group label: Minimum protein
arm group type: Experimental
intervention type: Other
intervention name: Lower limb immobilisation (leg brace) with varying levels of protein intake
description: Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
arm group label: High protein
arm group label: Low protein
arm group label: Minimum protein
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Muscular Atrophy
mesh term: Atrophy