<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/NCT04504799</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01613</org_study_id>
    <nct_id>NCT04504799</nct_id>
  </id_info>
  <brief_title>Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse</brief_title>
  <acronym>HAG-BIA</acronym>
  <official_title>Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masses by Comparison With Routinely Used Bioelectrical Impedance Analysis and Dual X-Ray Absorptiometry in Western Healthy Adults: The Geneva HAG-BIA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Claude Pichard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</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>
      Body composition measurement is an important tool for assessing the physical condition of&#xD;
      sick or healthy people, as well as for monitoring changes in body composition and physical&#xD;
      performance during diet and/or training. Many people self-monitor their body composition&#xD;
      using portable and inexpensive assessment tools, but most of them have not been tested for&#xD;
      accuracy and precision.&#xD;
&#xD;
      This study aims to assess the accuracy and precision of a new portable impedancemeter scale&#xD;
      to measure body composition in comparison with proven techniques, such as 4-electrode&#xD;
      electrical bioimpedance analysis and dual X-ray absorptiometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, prospective, cross-sectional study to evaluate the accuracy and&#xD;
      precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used&#xD;
      to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body&#xD;
      compositions according to gender specific BMI distributions in the population. Volunteers who&#xD;
      signed the informed consent form are included in the study. A financial compensation of 50.-&#xD;
      CHF is given to each participant (100.- to the 16 participants subjected to the DEXA&#xD;
      measurements).&#xD;
&#xD;
      The body composition of each subject (FM, LBM and FM%) is assessed with sequential&#xD;
      measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values&#xD;
      measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and&#xD;
      precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by&#xD;
      comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a&#xD;
      subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA&#xD;
      measurements (secondary objective). Pearson correlations and Bland-Altman graphs are&#xD;
      performed to assess the agreement of the measurements between the devices and paired t-tests&#xD;
      are used to determine if there is a bias between the devices. The significance of the&#xD;
      statistical analysis is fixed at p &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Actual">February 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of percent fat mass measurement</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison between HAG-B19 and Nutriguard-M measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra- and inter-device variability of percent fat mass measurement</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of measurements within and between three HAG-B19 devices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of percent fat mass measurement compared to gold standard</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison between HAG-B19 and DEXA in 10 percents of participants</description>
  </secondary_outcome>
  <enrollment type="Actual">160</enrollment>
  <condition>Body Composition</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Body composition measurement with HAG-BIA scale</intervention_name>
    <description>Bio-impendance analysis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Caucasians/Hispanics adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy Caucasians/Hispanics adults who signed the informed consent form (healthy defined&#xD;
        as no chronic disease, no hospitalisation for the last 6 months, no physical disability)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;18.5 or ≥ 30 kg/m2&#xD;
&#xD;
          -  No informed consent form signed&#xD;
&#xD;
          -  Inability to understand the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant.&#xD;
&#xD;
          -  Medication impacting fluid and electrolyte balance (diuretics or calcium channel&#xD;
             blocker)&#xD;
&#xD;
          -  Moderate to intense level physical activity 2-3 h before measurement&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Pichard, Prof</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <state>Geneva 14</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Prof. Claude Pichard</investigator_full_name>
    <investigator_title>Head, Clinical Nutrition</investigator_title>
  </responsible_party>
  <keyword>Body composition</keyword>
  <keyword>Bioimpendance analysis</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Nutrition</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04504799
org study id: 2020-01613
nct id: NCT04504799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Body composition measurement is an important tool for assessing the physical condition of
      sick or healthy people, as well as for monitoring changes in body composition and physical
      performance during diet and/or training. Many people self-monitor their body composition
      using portable and inexpensive assessment tools, but most of them have not been tested for
      accuracy and precision.

      This study aims to assess the accuracy and precision of a new portable impedancemeter scale
      to measure body composition in comparison with proven techniques, such as 4-electrode
      electrical bioimpedance analysis and dual X-ray absorptiometry.
This is an observational, prospective, cross-sectional study to evaluate the accuracy and
      precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used
      to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body
      compositions according to gender specific BMI distributions in the population. Volunteers who
      signed the informed consent form are included in the study. A financial compensation of 50.-
      CHF is given to each participant (100.- to the 16 participants subjected to the DEXA
      measurements).

      The body composition of each subject (FM, LBM and FM%) is assessed with sequential
      measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values
      measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and
      precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by
      comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a
      subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA
      measurements (secondary objective). Pearson correlations and Bland-Altman graphs are
      performed to assess the agreement of the measurements between the devices and paired t-tests
      are used to determine if there is a bias between the devices. The significance of the
      statistical analysis is fixed at p <0.05.
observational model: Case-Control
time perspective: Prospective
measure: Accuracy of percent fat mass measurement
time frame: 6 months
description: Comparison between HAG-B19 and Nutriguard-M measurement
measure: Intra- and inter-device variability of percent fat mass measurement
time frame: 6 months
description: Comparison of measurements within and between three HAG-B19 devices.
measure: Accuracy of percent fat mass measurement compared to gold standard
time frame: 6 months
description: Comparison between HAG-B19 and DEXA in 10 percents of participants
intervention type: Device
intervention name: Body composition measurement with HAG-BIA scale
description: Bio-impendance analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claude Pichard, Prof
role: Study Director
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Prof. Claude Pichard
investigator title: Head, Clinical Nutrition
sharing ipd: Undecided