<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/NCT02980952</url>
  </required_header>
  <id_info>
    <org_study_id>157758/03</org_study_id>
    <nct_id>NCT02980952</nct_id>
  </id_info>
  <brief_title>Amino Acid Balance During Physical Inactivity</brief_title>
  <official_title>Amino Acid Balance During Physical Inactivity</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to assess the impact of physical inactivity on muscle amino acid balance and&#xD;
      forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate&#xD;
      muscle amino acid balance and forearm glucose uptake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance&#xD;
      and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during&#xD;
      immobilization will modulate muscle amino acid balance and forearm glucose uptake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle amino acid balance</measure>
    <time_frame>3 hours</time_frame>
    <description>Forearm muscle amino acid balance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose uptake</measure>
    <time_frame>3 hours</time_frame>
    <description>Forearm glucose uptake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Assessing Muscle Amino Acid Balance</condition>
  <arm_group>
    <arm_group_label>Energy-balanced diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Forearm immobilization whilst consuming an energy-balanced diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-fat overfeeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forearm immobilization whilst consuming a high-fat diet, 50% energy excess</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-fat overfeeding</intervention_name>
    <arm_group_label>High-fat overfeeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Forearm immobilization</intervention_name>
    <arm_group_label>Energy-balanced diet</arm_group_label>
    <arm_group_label>High-fat overfeeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 18 and 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).&#xD;
&#xD;
          -  Any diagnosed cardiovascular disease or hypertension.&#xD;
&#xD;
          -  Elevated blood pressure at the time of screening. (An average systolic blood pressure&#xD;
             reading of ≥140 mmHg over two or more measurements and an average diastolic blood&#xD;
             pressure of ≥90 mmHg over two or more measurements.)&#xD;
&#xD;
          -  Chronic use of any prescribed or over the counter pharmaceuticals.&#xD;
&#xD;
          -  Regular use of nutritional supplements (e.g. creatine, protein supplementation)&#xD;
&#xD;
          -  Metallic implants (including heart pacemaker, cochlear implants, medication pumps,&#xD;
             surgical clips, plates or screws).&#xD;
&#xD;
          -  A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.&#xD;
&#xD;
          -  Any previous motor disorders.&#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>
  <overall_official>
    <last_name>Benjamin T Wall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Exeter</affiliation>
  </overall_official>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02980952
org study id: 157758/03
nct id: NCT02980952
lead sponsor: 
has dmc: No
The aim is to assess the impact of physical inactivity on muscle amino acid balance and
      forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate
      muscle amino acid balance and forearm glucose uptake.
The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance
      and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during
      immobilization will modulate muscle amino acid balance and forearm glucose uptake.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Muscle amino acid balance
time frame: 3 hours
description: Forearm muscle amino acid balance
measure: Glucose uptake
time frame: 3 hours
description: Forearm glucose uptake
arm group label: Energy-balanced diet
arm group type: Placebo Comparator
description: Forearm immobilization whilst consuming an energy-balanced diet
arm group label: High-fat overfeeding
arm group type: Experimental
description: Forearm immobilization whilst consuming a high-fat diet, 50% energy excess
intervention type: Other
intervention name: High-fat overfeeding
arm group label: High-fat overfeeding
intervention type: Other
intervention name: Forearm immobilization
arm group label: Energy-balanced diet
arm group label: High-fat overfeeding
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin T Wall, PhD
role: Principal Investigator
affiliation: University of Exeter
responsible party type: Sponsor
sharing ipd: No