<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/NCT02981927</url>
  </required_header>
  <id_info>
    <org_study_id>157758/02</org_study_id>
    <nct_id>NCT02981927</nct_id>
  </id_info>
  <brief_title>Bed Rest, Inactivity and Early Responses</brief_title>
  <acronym>BIER</acronym>
  <official_title>Bed Rest, Inactivity and Early Responses</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>
      To evaluate the early metabolic responses (whole body and within muscle tissue) to a single&#xD;
      day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of&#xD;
      inactivity per se vs alterations in diet&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2, 2016</completion_date>
  <primary_completion_date type="Actual">December 2, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose tolerance</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Metabolic Responses to Inactivity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>24 h habitual physical activity fed in energy balance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bed rest matched diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 hour period of whole body bed-rest with a matched diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bed rest balanced diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 hour period of whole body bed-rest fed in energy balance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical inactivity</intervention_name>
    <arm_group_label>Bed rest balanced diet</arm_group_label>
    <arm_group_label>Bed rest matched diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy and aged 18-40 y&#xD;
&#xD;
          -  BMI between 18 and 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On medication&#xD;
&#xD;
          -  Family history of metabolic disease&#xD;
&#xD;
          -  Diagnosed with any metabolic or cardiovascular conditions&#xD;
&#xD;
          -  BMI &lt; 18 or &gt; 30&#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>Sport &amp; Health Sciences</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>May 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 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/NCT02981927
org study id: 157758/02
nct id: NCT02981927
lead sponsor: 
has dmc: No
To evaluate the early metabolic responses (whole body and within muscle tissue) to a single
      day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of
      inactivity per se vs alterations in diet
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Glucose tolerance
time frame: 24 hours
arm group label: Control
arm group type: No Intervention
description: 24 h habitual physical activity fed in energy balance
arm group label: Bed rest matched diet
arm group type: Experimental
description: 24 hour period of whole body bed-rest with a matched diet
arm group label: Bed rest balanced diet
arm group type: Experimental
description: 24 hour period of whole body bed-rest fed in energy balance
intervention type: Other
intervention name: Physical inactivity
arm group label: Bed rest balanced diet
arm group label: Bed rest matched diet
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No