<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/NCT02992639</url>
  </required_header>
  <id_info>
    <org_study_id>VFA_liver enzyme</org_study_id>
    <nct_id>NCT02992639</nct_id>
  </id_info>
  <brief_title>Weight Loss Effect on Circulating Liver Enzymes</brief_title>
  <official_title>Weight Loss Effect on Circulating Levels of Liver Enzymes in Overweight Subjects With High Visceral Fat Area: 12-week Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <brief_summary>
    <textblock>
      To investigate weight loss effect with mild calorie restriction on circulating levels of&#xD;
      liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral&#xD;
      fat area (VFA) at L4 ≥ 100 cm²].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight&#xD;
      subjects with high VFA. The participants divided into two groups: 12-week mild calorie&#xD;
      restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The&#xD;
      randomization was according to computer-generated block randomization (placebo:test = 1:1).&#xD;
      Before and after intervention period, venous blood samples were obtained from the subjects,&#xD;
      and biochemical parameters including circulating liver enzymes were measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visceral fat area at L4 (CT)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Visceral fat area at L4 (CT)</measure>
    <time_frame>At 12-week follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline visceral fat area at L4 at 12-week (CT)</measure>
    <time_frame>At baseline and 12-week follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum fatty acid levels (Relative peak area)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum fatty acid levels (Relative peak area)</measure>
    <time_frame>At 12-week follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fat percentage (DEXA)</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat percentage (DEXA)</measure>
    <time_frame>At 12-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline fat percentage at 12-week (DEXA)</measure>
    <time_frame>At baseline and 12-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass (DEXA)</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass (DEXA)</measure>
    <time_frame>At 12-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline fat mass at 12-week (DEXA)</measure>
    <time_frame>At baseline and 12-week follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Visceral Fat</condition>
  <condition>Liver Dysfunction</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No calorie restriction group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight loss group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mild calorie restriction group (300kcal/day intake reduction)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The participants who included in control group did not receive any treatment.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight loss group</intervention_name>
    <description>The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes</description>
    <arm_group_label>Weight loss group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  20-60 years old&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Overweight (25.0 kg/m²≤ BMI &lt;30 kg/m²)&#xD;
&#xD;
          -  Absence of pregnancy or breast-feeding&#xD;
&#xD;
          -  Stable body weight (body weight change &lt;1kg for 3 months before screening)&#xD;
&#xD;
          -  High visceral fat (VFA) at L4 (VFA at L4 ≥100 cm²)&#xD;
&#xD;
          -  Without hypertension, type 2 diabetes, cardiovascular disease, or thyroid disease&#xD;
&#xD;
          -  No use medication affecting body weight, energy expenditure, or glucose control for&#xD;
             the last 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of Cushing syndrome or malignancy&#xD;
&#xD;
          -  Prior history of liver disease including chronic viral hepatitis, autoimmune&#xD;
             hepatitis, primary biliary cirrhosis, or drug-induced liver disease&#xD;
&#xD;
          -  Excess alcohol intake (based on WHO standard)&#xD;
&#xD;
          -  History of intentional reduction in weight in the preceding 6 months&#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>Jong Ho Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei University</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 14, 2017</last_update_submitted>
  <last_update_submitted_qc>February 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High visceral fat</keyword>
  <keyword>Liver enzymes</keyword>
  <keyword>Aminotransferase</keyword>
  <keyword>Mild calorie restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT02992639
org study id: VFA_liver enzyme
nct id: NCT02992639
lead sponsor: 
To investigate weight loss effect with mild calorie restriction on circulating levels of
      liver enzymes in nondiabetic and overweight subjects with high visceral fat area [visceral
      fat area (VFA) at L4 ≥ 100 cm²].
A 12-week randomized, placebo-controlled study was conducted on 80 nondiabetic and overweight
      subjects with high VFA. The participants divided into two groups: 12-week mild calorie
      restriction (a 300 kcal/day intake reduction, n=40) or no treatment (control, n=40). The
      randomization was according to computer-generated block randomization (placebo:test = 1:1).
      Before and after intervention period, venous blood samples were obtained from the subjects,
      and biochemical parameters including circulating liver enzymes were measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visceral fat area at L4 (CT)
time frame: At baseline
measure: Visceral fat area at L4 (CT)
time frame: At 12-week follow-up
measure: Change from baseline visceral fat area at L4 at 12-week (CT)
time frame: At baseline and 12-week follow-up
measure: Serum fatty acid levels (Relative peak area)
time frame: At baseline
measure: Serum fatty acid levels (Relative peak area)
time frame: At 12-week follow-up
measure: Fat percentage (DEXA)
time frame: At baseline
measure: Fat percentage (DEXA)
time frame: At 12-week follow-up
measure: Change from baseline fat percentage at 12-week (DEXA)
time frame: At baseline and 12-week follow-up
measure: Fat mass (DEXA)
time frame: At baseline
measure: Fat mass (DEXA)
time frame: At 12-week follow-up
measure: Change from baseline fat mass at 12-week (DEXA)
time frame: At baseline and 12-week follow-up
arm group label: Control group
arm group type: Placebo Comparator
description: No calorie restriction group
arm group label: Weight loss group
arm group type: Experimental
description: Mild calorie restriction group (300kcal/day intake reduction)
intervention type: Behavioral
intervention name: Control group
description: The participants who included in control group did not receive any treatment.
arm group label: Control group
intervention type: Behavioral
intervention name: Weight loss group
description: The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes
arm group label: Weight loss group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jong Ho Lee, PhD
role: Principal Investigator
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Weight Loss