<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/NCT04469452</url>
  </required_header>
  <id_info>
    <org_study_id>20-0317</org_study_id>
    <nct_id>NCT04469452</nct_id>
  </id_info>
  <brief_title>Validation of a Portable Indirect Calorimeter</brief_title>
  <official_title>Validation of the Apollo EE Device, Indirect Calorimetry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study plans to test the accuracy of a new device (the Apollo EE Device) that measures&#xD;
      resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study&#xD;
      will help determine how this new device compares to the gold standard, indirect calorimetry,&#xD;
      which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop&#xD;
      less expensive and more accessible means of measuring energy expenditure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure&#xD;
      oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2&#xD;
      ranges from ~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein&#xD;
      oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively&#xD;
      small effect on energy expenditure estimation. A device that measures RMR based on VO2 and&#xD;
      eliminates the need for measuring VCO2 could provide a simple and less expensive alternative&#xD;
      to metabolic carts and may have important clinical applications. The overarching goal of this&#xD;
      proposal is to validate such a metabolic system by comparing its ability to accurately&#xD;
      measure RMR against a metabolic cart.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of RMR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)</measure>
    <time_frame>Repeated Measure obtained within 1 week of baseline measure</time_frame>
    <description>Repeated measurement of RMR</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Human Energy Expenditure</condition>
  <arm_group>
    <arm_group_label>Healthy Adults (19-99yrs)</arm_group_label>
    <description>Healthy adults already enrolled in separate studies using indirect calorimetry to measure RMR within our lab will be recruited for this study. Fifty participants (25 male, 25 female) will be heterogeneous in age, body composition, and physical activity based on the inclusion and exclusion of their respective studies. To test reliability, 25 of the 50 participants will repeat RMR measurements within 1 week of initial measurements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apollo Device</intervention_name>
    <description>Comparisons will be made between the Apollo EE Device (Sable Systems International, Las Vegas, NV) and the TrueOne 2400 metabolic cart (Parvo Medics, Salt Lake City, UT)</description>
    <arm_group_label>Healthy Adults (19-99yrs)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Only individuals who are enrolled in a separate study using indirect calorimetry to measure&#xD;
        RMR within our lab will be eligible to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  19-99 yrs of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward Melanson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mallory Boyd, M.S</last_name>
    <phone>303-724-4300</phone>
    <email>mallory.boyd@cuanschutz.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</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/NCT04469452
org study id: 20-0317
nct id: NCT04469452
lead sponsor: 
has dmc: No
is fda regulated device: No
This study plans to test the accuracy of a new device (the Apollo EE Device) that measures
      resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study
      will help determine how this new device compares to the gold standard, indirect calorimetry,
      which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop
      less expensive and more accessible means of measuring energy expenditure.
The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure
      oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2
      ranges from ~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein
      oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively
      small effect on energy expenditure estimation. A device that measures RMR based on VO2 and
      eliminates the need for measuring VCO2 could provide a simple and less expensive alternative
      to metabolic carts and may have important clinical applications. The overarching goal of this
      proposal is to validate such a metabolic system by comparing its ability to accurately
      measure RMR against a metabolic cart.
observational model: Other
time perspective: Cross-Sectional
measure: Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
time frame: Baseline
description: Measurement of RMR
measure: Reliability of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
time frame: Repeated Measure obtained within 1 week of baseline measure
description: Repeated measurement of RMR
arm group label: Healthy Adults (19-99yrs)
description: Healthy adults already enrolled in separate studies using indirect calorimetry to measure RMR within our lab will be recruited for this study. Fifty participants (25 male, 25 female) will be heterogeneous in age, body composition, and physical activity based on the inclusion and exclusion of their respective studies. To test reliability, 25 of the 50 participants will repeat RMR measurements within 1 week of initial measurements.
intervention type: Device
intervention name: Apollo Device
description: Comparisons will be made between the Apollo EE Device (Sable Systems International, Las Vegas, NV) and the TrueOne 2400 metabolic cart (Parvo Medics, Salt Lake City, UT)
arm group label: Healthy Adults (19-99yrs)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edward Melanson, Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Mallory Boyd, M.S
phone: 303-724-4300
email: mallory.boyd@cuanschutz.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
sharing ipd: No