<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/NCT01667224</url>
  </required_header>
  <id_info>
    <org_study_id>TgBio-TG1022-001</org_study_id>
    <nct_id>NCT01667224</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.</brief_title>
  <official_title>Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is a major health issue worldwide; there is a constant raise in obesity related death&#xD;
      each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.&#xD;
      However, the efficacy and safety of Actiponin supplementation on body weight regulation in&#xD;
      humans are lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on&#xD;
      body weight and fat loss along with changes in metabolic markers based on 12 week,&#xD;
      randomized, double-blind, placebo-controlled clinical trial.&#xD;
&#xD;
      Eighty obesity subjects with BMI &gt; 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥&#xD;
      0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group&#xD;
      (n=40, 450mg/day) for 12weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">October 2010</completion_date>
  <primary_completion_date type="Actual">August 2010</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Body Fat Mass.</measure>
    <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)</time_frame>
    <description>Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Abdominal Total Fat Area.</measure>
    <time_frame>study visit 1(0 week), visit 4(12 week)</time_frame>
    <description>Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Weight.</measure>
    <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)</time_frame>
    <description>Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Mss Index(BMI)</measure>
    <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)</time_frame>
    <description>BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Actiponin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo(450mg/day) for 12weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Actiponin</intervention_name>
    <description>The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
    <arm_group_label>Actiponin</arm_group_label>
    <other_name>Extract of Gynostemma pentaphyllum(450mg/day)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Amount and calorie of placebo are same with Actiponin.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo(450mg/day)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant variation in weight(more 10%) in the past 3 months&#xD;
&#xD;
          -  Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and&#xD;
             patient with pacemaker&#xD;
&#xD;
          -  History of disease that could interfere with the test products or impede theire&#xD;
             absorption, such as gastrointestinal disease or gastrointestinal surgery&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Abdominal hepatic liver function&#xD;
&#xD;
          -  Renal disease, e.g. acute/chronic renal failure, nephritic syndrome&#xD;
&#xD;
          -  Used antipsychosis drugs therapy within past 2 months&#xD;
&#xD;
          -  Laboratory test, medical or psychological conditions deemed by the investigators to&#xD;
             interfere with successful participation in the study&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soo-Wan Chae, Ph.D, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>March 16, 2014</results_first_submitted>
  <results_first_submitted_qc>March 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 21, 2014</results_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-Wan Chae</investigator_full_name>
    <investigator_title>Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <keyword>Actiponin</keyword>
  <keyword>Obesity</keyword>
  <keyword>Abdominal fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2009. Only those subjects who were obese[both BMI≥25kg/m2 and WHR≥0.90(men), WHR≥0.85(women)] and were not diagnosed with any disease were included in this study.</recruitment_details>
      <pre_assignment_details>Among the 105 subjets screened, 25 subjects had anthropometric and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Actiponin</title>
          <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Actiponin</title>
          <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.10" spread="9.67"/>
                    <measurement group_id="B2" value="40.05" spread="11.58"/>
                    <measurement group_id="B3" value="40.08" spread="10.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Body Fat Mass.</title>
        <description>Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
        <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Actiponin</title>
            <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Body Fat Mass.</title>
          <description>Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.65" spread="3.12"/>
                    <measurement group_id="O2" value="23.04" spread="3.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.28" spread="3.45"/>
                    <measurement group_id="O2" value="23.17" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.89" spread="3.35"/>
                    <measurement group_id="O2" value="23.15" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" spread="3.62"/>
                    <measurement group_id="O2" value="23.32" spread="3.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Abdominal Total Fat Area.</title>
        <description>Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).</description>
        <time_frame>study visit 1(0 week), visit 4(12 week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Actiponin</title>
            <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Abdominal Total Fat Area.</title>
          <description>Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).</description>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="332.24" spread="10.65"/>
                    <measurement group_id="O2" value="335.36" spread="7.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="311.35" spread="9.04"/>
                    <measurement group_id="O2" value="333.05" spread="8.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Body Weight.</title>
        <description>Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
        <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Actiponin</title>
            <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Body Weight.</title>
          <description>Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.56" spread="8.31"/>
                    <measurement group_id="O2" value="73.41" spread="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.26" spread="8.35"/>
                    <measurement group_id="O2" value="73.53" spread="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.57" spread="8.18"/>
                    <measurement group_id="O2" value="73.33" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.21" spread="8.2"/>
                    <measurement group_id="O2" value="73.33" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Body Mss Index(BMI)</title>
        <description>BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).</description>
        <time_frame>study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Actiponin(450mg/Day) for 12week</title>
            <description>Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (450mg/Day) for 12 Week</title>
            <description>Placebo: Amount and calorie of placebo are same with Actiponin</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Body Mss Index(BMI)</title>
          <description>BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" spread="1.21"/>
                    <measurement group_id="O2" value="27.55" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.69" spread="1.17"/>
                    <measurement group_id="O2" value="27.61" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.44" spread="1.28"/>
                    <measurement group_id="O2" value="27.54" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.31" spread="1.24"/>
                    <measurement group_id="O2" value="27.55" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Actiponin</title>
          <description>Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks&#xD;
Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo(450mg/day) for 12weeks&#xD;
Placebo : Amount and calorie of placebo are same with Actiponin.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Soo-Wan Chae</name_or_title>
      <organization>Clinical Trial Center for Functional Food in Chonbuk National University Hospital</organization>
      <phone>82-63-250-2348</phone>
      <email>soowan@jbnu.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01667224
org study id: TgBio-TG1022-001
nct id: NCT01667224
lead sponsor: 
has dmc: Yes
Obesity is a major health issue worldwide; there is a constant raise in obesity related death
      each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.
      However, the efficacy and safety of Actiponin supplementation on body weight regulation in
      humans are lacking.
The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on
      body weight and fat loss along with changes in metabolic markers based on 12 week,
      randomized, double-blind, placebo-controlled clinical trial.

      Eighty obesity subjects with BMI > 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥
      0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group
      (n=40, 450mg/day) for 12weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in Body Fat Mass.
time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
description: Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
measure: Changes in Abdominal Total Fat Area.
time frame: study visit 1(0 week), visit 4(12 week)
description: Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).
measure: Changes in Body Weight.
time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)
description: Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
measure: Changes in Body Mss Index(BMI)
time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
description: BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).
arm group label: Actiponin
arm group type: Experimental
description: Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo(450mg/day) for 12weeks
intervention type: Dietary Supplement
intervention name: Actiponin
description: The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
arm group label: Actiponin
other name: Extract of Gynostemma pentaphyllum(450mg/day)
intervention type: Dietary Supplement
intervention name: Placebo
description: Amount and calorie of placebo are same with Actiponin.
arm group label: Placebo
other name: Placebo(450mg/day)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soo-Wan Chae, Ph.D, MD
role: Study Chair
affiliation: Chonbuk National University Hospital
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Clinical Trial Center for Functional Foods
mesh term: Obesity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 