<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/NCT04429581</url>
  </required_header>
  <id_info>
    <org_study_id>23/02/2013</org_study_id>
    <nct_id>NCT04429581</nct_id>
  </id_info>
  <brief_title>Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.</brief_title>
  <official_title>Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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 objective of the present study was to analyze the differences between the formulas used&#xD;
      to estimate fat mass and to establish the existing relationship with the skinfold sum in&#xD;
      anthropometry. A total of 2,458 active subjects participated in the study (mean age:&#xD;
      27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the&#xD;
      guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and&#xD;
      Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass.&#xD;
      Significative differences were found between all the formulas for the percentage of fat mass&#xD;
      and the fat mass in kilograms. The correlations among the skinfolds sums and the different&#xD;
      equations were high and significative in all the cases. There were differences between all&#xD;
      the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid&#xD;
      and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat&#xD;
      mass in physically active adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2013</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</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>Fat mass weight</measure>
    <time_frame>6 years</time_frame>
    <description>Fat mass weight was assessed with skinfold measurements and different prediction equations. Measured in kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat mass percentage</measure>
    <time_frame>6 years</time_frame>
    <description>Fat mass percentage was assessed with skinfold measurements and different prediction equations. Measured in percentage of total weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six and eight skinfold sums</measure>
    <time_frame>6 years</time_frame>
    <description>Skinfolds were measured with a caliper, using anthropometry technique describes by ISAK</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>6 years</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>6 years</time_frame>
    <description>Measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>6 years</time_frame>
    <description>Measured in meters</description>
  </secondary_outcome>
  <enrollment type="Actual">2458</enrollment>
  <condition>Body Weight Changes</condition>
  <condition>Body Weight</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anthropometry</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The present study was conducted with a sample of 2,458 active subjects (mean age:&#xD;
        27,98±7,43 year-old), 1775 men (mean age: 27,99±7,46 years) and 681 women (mean age:&#xD;
        27,94±7,37 years) from Región de Murcia (Spain)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be between 18 and 50 years old and to practice any sport in a regular basis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have overweight or obesity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Francisco Esparza Ros</investigator_full_name>
    <investigator_title>Director of the International Chair of Kinanthropometry</investigator_title>
  </responsible_party>
  <keyword>Fat mass</keyword>
  <keyword>Body composition assessement</keyword>
  <keyword>Health</keyword>
  <keyword>Antropometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
  </condition_browse>
  <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/NCT04429581
org study id: 23/02/2013
nct id: NCT04429581
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the present study was to analyze the differences between the formulas used
      to estimate fat mass and to establish the existing relationship with the skinfold sum in
      anthropometry. A total of 2,458 active subjects participated in the study (mean age:
      27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the
      guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and
      Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass.
      Significative differences were found between all the formulas for the percentage of fat mass
      and the fat mass in kilograms. The correlations among the skinfolds sums and the different
      equations were high and significative in all the cases. There were differences between all
      the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid
      and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat
      mass in physically active adults.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Fat mass weight
time frame: 6 years
description: Fat mass weight was assessed with skinfold measurements and different prediction equations. Measured in kilograms
measure: Fat mass percentage
time frame: 6 years
description: Fat mass percentage was assessed with skinfold measurements and different prediction equations. Measured in percentage of total weight.
measure: Six and eight skinfold sums
time frame: 6 years
description: Skinfolds were measured with a caliper, using anthropometry technique describes by ISAK
measure: Body Mass Index
time frame: 6 years
description: Weight and height will be combined to report BMI in kg/m^2
measure: Weight
time frame: 6 years
description: Measured in kilograms
measure: Height
time frame: 6 years
description: Measured in meters
intervention type: Other
intervention name: Anthropometry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Francisco Esparza Ros
investigator title: Director of the International Chair of Kinanthropometry
mesh term: Body Weight
mesh term: Body Weight Changes
sharing ipd: No