<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/NCT03260751</url>
  </required_header>
  <id_info>
    <org_study_id>WJ-BF-ZO</org_study_id>
    <nct_id>NCT03260751</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat</brief_title>
  <official_title>A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to investigate the effects of daily supplementation of Zingiber&#xD;
      officinale Roscoe extract on body fat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty&#xD;
      subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo&#xD;
      group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and&#xD;
      body mass index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">January 29, 2018</completion_date>
  <primary_completion_date type="Actual">January 29, 2018</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of body fat mass</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Body fat mass was measured in study baseline and 12 week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of percent body fat</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Percent body fat was measured in study baseline and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of fat free mass</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Fat Free Mass was measured in study baseline and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of weight</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Weight was measured in study baseline and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of body mass index</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Body mass index was measured in study baseline and 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>Zingiber officinale Roscoe extract 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 cap/day, 800 mg/cap for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Zingiber officinale Roscoe extract 200 mg</intervention_name>
    <description>2 cap/day, 800 mg/cap for 12 weeks</description>
    <arm_group_label>Zingiber officinale Roscoe extract 200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 12 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 19 and 65 years,&#xD;
&#xD;
          -  BMI 25~29.9 kg/m2&#xD;
&#xD;
          -  subjects giving written informed consent&#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 their&#xD;
             absorption, such as gastrointestinal disease or gastrointestinal surgery&#xD;
&#xD;
          -  Participation in any other clinical trials 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 etc,.&#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>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</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>Principal investigator, Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <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/NCT03260751
org study id: WJ-BF-ZO
nct id: NCT03260751
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to investigate the effects of daily supplementation of Zingiber
      officinale Roscoe extract on body fat.
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty
      subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo
      group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and
      body mass index.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of body fat mass
time frame: Baseline and 12 week
description: Body fat mass was measured in study baseline and 12 week
measure: Changes of percent body fat
time frame: Baseline and 12 week
description: Percent body fat was measured in study baseline and 12 week
measure: Changes of fat free mass
time frame: Baseline and 12 week
description: Fat Free Mass was measured in study baseline and 12 week
measure: Changes of weight
time frame: Baseline and 12 week
description: Weight was measured in study baseline and 12 week
measure: Changes of body mass index
time frame: Baseline and 12 week
description: Body mass index was measured in study baseline and 12 week
arm group label: Zingiber officinale Roscoe extract 200 mg
arm group type: Experimental
description: 2 cap/day, 800 mg/cap for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: Zingiber officinale Roscoe extract 200 mg
description: 2 cap/day, 800 mg/cap for 12 weeks
arm group label: Zingiber officinale Roscoe extract 200 mg
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 12 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal investigator, Clinical Trial Center for Functional Foods
sharing ipd: Undecided