<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/NCT03826212</url>
  </required_header>
  <id_info>
    <org_study_id>NOVA-BF-SBG</org_study_id>
    <nct_id>NCT03826212</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat</brief_title>
  <official_title>A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Soybean Germ Extract on Decrease of 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 Soybean germ&#xD;
      extract on decrease of body fat&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80&#xD;
      subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The&#xD;
      investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass&#xD;
      index, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2020</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>Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report percent body fat in %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of fat free mass</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report fat free mass in g.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Anthropometric indicate: body weight</measure>
    <time_frame>Screening, baseline and 12 week</time_frame>
    <description>Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Anthropometric indicate: body mass index</measure>
    <time_frame>Screening, baseline and 12 week</time_frame>
    <description>Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height^2 will be report body mass index in kg/m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Anthropometric indices: waist circumference, hip circumference</measure>
    <time_frame>Screening, baseline and 12 week</time_frame>
    <description>Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Anthropometric indicate: waist -hip circumference ratio</measure>
    <time_frame>Screening, baseline and 12 week</time_frame>
    <description>Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of obesity-related hormones indicators: Adiponectin, Leptin</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>obesity-related hormones indicators were measured in study baseline and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)</measure>
    <time_frame>Baseline and 12 week</time_frame>
    <description>energy expenditure Indicators were measured in study baseline and 12 week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Soybean Germ Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soybean Germ Extract 1,600 mg/day 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 1,600 mg/day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soybean Germ Extract</intervention_name>
    <description>Soybean Germ Extract 1,600 mg/day for 12 weeks.</description>
    <arm_group_label>Soybean Germ Extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 1,600 mg/day 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/m^2&#xD;
&#xD;
          -  After fully hearing and fully understanding this clinical trials, those who agree to&#xD;
             voluntarily decide to participate and to comply with the notice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who lost more than 10% of their weight within 3 months before the screening&#xD;
&#xD;
          -  Those who take a product(body fat improvement health functional foods, birth control&#xD;
             pills, steroids, female hormone) that affects your weight within 4 weeks prior to the&#xD;
             screening&#xD;
&#xD;
          -  Those with clinically significant severe cardiovascular, endocrine, immune,&#xD;
             respiratory, liver, biliary, renal and urinary tract, neuropsychiatry,&#xD;
             musculoskeletal, inflammatory and hematologic and gastrointestinal disorders&#xD;
&#xD;
          -  Diabetic patients taking oral hypoglycemic agents or insulin (based on screening&#xD;
             subjects)&#xD;
&#xD;
          -  A person with a history of clinically significant hypersensitivity to soybeans&#xD;
&#xD;
          -  Those who have received antipsychotic medication within 2 months before screening&#xD;
&#xD;
          -  Anyone with substance abuse or suspicion&#xD;
&#xD;
          -  Those who participated in other clinical trials within 3 months before screening&#xD;
&#xD;
          -  Systolic Blood Pressure(SBP) 180 mmHg, Diastolic Blood Pressure(DBP) 110 mmHg or more&#xD;
&#xD;
          -  Menopausal woman&#xD;
&#xD;
          -  Laboratory test by show the following results&#xD;
&#xD;
               -  Aspartate Transaminase(AST), Alanine Transaminase(ALT) &gt; Reference range 3 times&#xD;
                  upper limit&#xD;
&#xD;
               -  Serum Creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Those who doesn't accept the implementation of appropriate contraception of a&#xD;
             childbearing woman&#xD;
&#xD;
          -  Principal Investigator judged inappropriate for participation in study because of&#xD;
             Laboratory test result, 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>
  <overall_contact>
    <last_name>Soo Wan Chae, Ph.D., M.D.</last_name>
    <phone>82-63-259-3040</phone>
    <email>soowan@jbnu.ac.kr</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Soo-Wan Chae, MD., PhD</last_name>
      <phone>82-63-259-3040</phone>
      <email>swchae@jbctc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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>
  <!-- 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/NCT03826212
org study id: NOVA-BF-SBG
nct id: NCT03826212
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 Soybean germ
      extract on decrease of body fat
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80
      subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The
      investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass
      index, etc.
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: Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report percent body fat in %.
measure: Changes of fat free mass
time frame: Baseline and 12 week
description: Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report fat free mass in g.
measure: Changes of Anthropometric indicate: body weight
time frame: Screening, baseline and 12 week
description: Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg.
measure: Changes of Anthropometric indicate: body mass index
time frame: Screening, baseline and 12 week
description: Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height^2 will be report body mass index in kg/m^2.
measure: Changes of Anthropometric indices: waist circumference, hip circumference
time frame: Screening, baseline and 12 week
description: Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm.
measure: Changes of Anthropometric indicate: waist -hip circumference ratio
time frame: Screening, baseline and 12 week
description: Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio.
measure: Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol
time frame: Baseline and 12 week
description: Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week.
measure: Changes of obesity-related hormones indicators: Adiponectin, Leptin
time frame: Baseline and 12 week
description: obesity-related hormones indicators were measured in study baseline and 12 week
measure: Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)
time frame: Baseline and 12 week
description: energy expenditure Indicators were measured in study baseline and 12 week
arm group label: Soybean Germ Extract
arm group type: Experimental
description: Soybean Germ Extract 1,600 mg/day for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 1,600 mg/day for 12 weeks.
intervention type: Dietary Supplement
intervention name: Soybean Germ Extract
description: Soybean Germ Extract 1,600 mg/day for 12 weeks.
arm group label: Soybean Germ Extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo 1,600 mg/day for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soo Wan Chae, Ph.D., M.D.
phone: 82-63-259-3040
email: soowan@jbnu.ac.kr
facility: 
status: Recruiting
contact: 
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