<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/NCT03779932</url>
  </required_header>
  <id_info>
    <org_study_id>BCA-20</org_study_id>
    <nct_id>NCT03779932</nct_id>
  </id_info>
  <brief_title>Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA</brief_title>
  <official_title>Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seca GmbH &amp; Co. Kg.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seca GmbH &amp; Co. Kg.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was based on the clinical trial BCA-01 (NCT01368640) &quot;Generation of prediction&#xD;
      equations to analyze body composition of adults based on Bioelectrical Impedance Analysis&#xD;
      (BIA)&quot; and implicates an extension of the study collective. Aim of the study is to develop&#xD;
      prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard&#xD;
      reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA&#xD;
      devices on the other hand.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2015</start_date>
  <completion_date type="Actual">February 24, 2016</completion_date>
  <primary_completion_date type="Actual">February 24, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BIA 5 and 50 kHz</measure>
    <time_frame>15 minutes</time_frame>
    <description>Bioelectrical Impedance of 5 and 50 kHz for one body side</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BIA 50 kHz</measure>
    <time_frame>15 minutes</time_frame>
    <description>Bioelectrical Impedance of 50 kHz for all 4 extremities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total body water</measure>
    <time_frame>15 minutes</time_frame>
    <description>Total body water (TBW) by deuterium (D2O) dilution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extracellular water</measure>
    <time_frame>15 minutes</time_frame>
    <description>Extracellular water (ECW) by NaBr dilution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat-free mass</measure>
    <time_frame>1 hour</time_frame>
    <description>Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal muscle mass</measure>
    <time_frame>1 hour</time_frame>
    <description>Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visceral adipose tissue</measure>
    <time_frame>1 hour</time_frame>
    <description>Visceral adipose tissue VAT by magnetic resonance imaging (MRI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete BIA</measure>
    <time_frame>15 minutes</time_frame>
    <description>Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.</description>
  </secondary_outcome>
  <enrollment type="Actual">38</enrollment>
  <condition>Bioelectrical Impedance Measurement of Healthy Adults</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        38 healthy obese adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults in an&#xD;
&#xD;
          -  age range of 18 to 65 years&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute and chronic diseases&#xD;
&#xD;
          -  regular intake of medications (except for contraceptives)&#xD;
&#xD;
          -  amputation of limbs&#xD;
&#xD;
          -  electrical implant as cardiac pacemaker&#xD;
&#xD;
          -  insulin pumps&#xD;
&#xD;
          -  artificial joints&#xD;
&#xD;
          -  metallic implants (except tooth implants)&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  pregnancy or breastfeeding period&#xD;
&#xD;
          -  probands who cannot provide an ICF by themselves&#xD;
&#xD;
          -  probands who might be dependent from the sponsor or the inv. site&#xD;
&#xD;
          -  current alcohol abuse&#xD;
&#xD;
          -  frequent hypersensitivity reactions/allergies determ. anamnestically&#xD;
&#xD;
          -  extensive tattoos at arms or legs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Manfred J Müller, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christian-Albrechts-University of Kiel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Human Nutrition and Food Science</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</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/NCT03779932
org study id: BCA-20
nct id: NCT03779932
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction
      equations to analyze body composition of adults based on Bioelectrical Impedance Analysis
      (BIA)" and implicates an extension of the study collective. Aim of the study is to develop
      prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard
      reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA
      devices on the other hand.
observational model: Case-Only
time perspective: Cross-Sectional
measure: BIA 5 and 50 kHz
time frame: 15 minutes
description: Bioelectrical Impedance of 5 and 50 kHz for one body side
measure: BIA 50 kHz
time frame: 15 minutes
description: Bioelectrical Impedance of 50 kHz for all 4 extremities
measure: Total body water
time frame: 15 minutes
description: Total body water (TBW) by deuterium (D2O) dilution
measure: Extracellular water
time frame: 15 minutes
description: Extracellular water (ECW) by NaBr dilution
measure: Fat-free mass
time frame: 1 hour
description: Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
measure: Skeletal muscle mass
time frame: 1 hour
description: Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
measure: Visceral adipose tissue
time frame: 1 hour
description: Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
measure: Complete BIA
time frame: 15 minutes
description: Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Manfred J Müller, Prof. Dr.
role: Principal Investigator
affiliation: Christian-Albrechts-University of Kiel
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No