<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/NCT03035903</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2016-086</org_study_id>
    <nct_id>NCT03035903</nct_id>
  </id_info>
  <brief_title>Energy Cost for Holding a MedGem® Indirect Calorimeter</brief_title>
  <acronym>MEDGEM</acronym>
  <official_title>Energy Cost for Holding a MedGem® Indirect Calorimeter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weight Watchers International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</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 goal of this clinical protocol is to perform a randomized crossover study to determine&#xD;
      the energy cost of holding the MedGem® device above a person's normal resting metabolic rate&#xD;
      (RMR) compared to not holding the MedGem® device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute&#xD;
      rest (washout) period. The two RMR evaluation periods are as follows:&#xD;
&#xD;
        1. RMR with MedGem® Indirect Calorimeter&#xD;
&#xD;
        2. RMR without MedGem® Indirect Calorimeter&#xD;
&#xD;
      Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures&#xD;
      will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects&#xD;
      will be introduced to the ventilated hood to determine presence of claustrophobia prior to&#xD;
      enrollment (i.e., signing of the consent form).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting Metabolic Rate (RMR)</measure>
    <time_frame>3 hours</time_frame>
    <description>Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Resting Metabolic Rate</condition>
  <arm_group>
    <arm_group_label>Not holding, then holding the MedGem®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Holding, then not holding the MedGem®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Not holding, then holding the MedGem®</intervention_name>
    <description>Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®</description>
    <arm_group_label>Holding, then not holding the MedGem®</arm_group_label>
    <arm_group_label>Not holding, then holding the MedGem®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Holding, then not holding the MedGem®</intervention_name>
    <description>Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®</description>
    <arm_group_label>Holding, then not holding the MedGem®</arm_group_label>
    <arm_group_label>Not holding, then holding the MedGem®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-65 y&#xD;
&#xD;
          -  BMI 25-40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Presently on a weight loss regimen&#xD;
&#xD;
          -  Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  Pacemaker or other metal implants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Ravussin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>June 1, 2018</last_update_submitted>
  <last_update_submitted_qc>June 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Eric Ravussin</investigator_full_name>
    <investigator_title>Associate Executive Director for Clinical Science</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.</ipd_description>
  </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/NCT03035903
org study id: PBRC 2016-086
nct id: NCT03035903
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this clinical protocol is to perform a randomized crossover study to determine
      the energy cost of holding the MedGem® device above a person's normal resting metabolic rate
      (RMR) compared to not holding the MedGem® device.
Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute
      rest (washout) period. The two RMR evaluation periods are as follows:

        1. RMR with MedGem® Indirect Calorimeter

        2. RMR without MedGem® Indirect Calorimeter

      Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures
      will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects
      will be introduced to the ventilated hood to determine presence of claustrophobia prior to
      enrollment (i.e., signing of the consent form).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Resting Metabolic Rate (RMR)
time frame: 3 hours
description: Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
arm group label: Not holding, then holding the MedGem®
arm group type: Experimental
description: Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.
arm group label: Holding, then not holding the MedGem®
arm group type: Active Comparator
description: Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.
intervention type: Device
intervention name: Not holding, then holding the MedGem®
description: Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®
arm group label: Holding, then not holding the MedGem®
arm group label: Not holding, then holding the MedGem®
intervention type: Device
intervention name: Holding, then not holding the MedGem®
description: Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®
arm group label: Holding, then not holding the MedGem®
arm group label: Not holding, then holding the MedGem®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Ravussin, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Eric Ravussin
investigator title: Associate Executive Director for Clinical Science
sharing ipd: No
ipd description: The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.