<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/NCT03774381</url>
  </required_header>
  <id_info>
    <org_study_id>02-2018-016</org_study_id>
    <nct_id>NCT03774381</nct_id>
  </id_info>
  <brief_title>Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults</brief_title>
  <official_title>Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan 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>
      Comparison of a randomized, double-blind, and control-group study for the effect of oral&#xD;
      ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body&#xD;
      fat reduction in adults by a randomized, double-blind, and control-group study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body fat</measure>
    <time_frame>Change from baseline body fat at 12 weeks</time_frame>
    <description>dual energy x-ray absorptiometry (DEXA)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Bifidobacterium breve B-3 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>160 mg of placebo was orally administered per day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bifidobacterium breve B-3</intervention_name>
    <description>160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.</description>
    <arm_group_label>Bifidobacterium breve B-3 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>160 mg of placebo is orally administered per day for 12 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 27~30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Within the last 6 months, severe cerebrovascular disease (cerebral infarction,&#xD;
             cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction,&#xD;
             heart failure, arrhythmia requiring treatment), or malignant diseases (however,&#xD;
             although subjects have a history of cerebrovascular disease and heart disease, they&#xD;
             can be included if their status are clinically stable)&#xD;
&#xD;
          -  Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)&#xD;
&#xD;
          -  Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl&#xD;
             or more&#xD;
&#xD;
          -  Those who are treated with hypothyroidism or hyperthyroidism&#xD;
&#xD;
          -  Creatinine levels: more than twice the normal upper limit&#xD;
&#xD;
          -  Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the&#xD;
             normal upper limit&#xD;
&#xD;
          -  Those complaining of severe gastrointestinal symptoms such as heartburn and&#xD;
             indigestion&#xD;
&#xD;
          -  Drugs that affect weight within the last month (absorption inhibitors and Appetite&#xD;
             suppressant, health food / supplements related to obesity improvement, psychiatric&#xD;
             Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If&#xD;
             you are taking&#xD;
&#xD;
          -  Participated in the commercial obesity program within the last 3 months.&#xD;
&#xD;
          -  If you have participated or are planning to participate in another clinical trial&#xD;
             within the past month If yes&#xD;
&#xD;
          -  Alcohol abuser&#xD;
&#xD;
          -  Smoking abstinence within 3 months&#xD;
&#xD;
          -  If they are pregnant or lactating or have a pregnancy plan during the clinical trial&#xD;
&#xD;
          -  Those with allergic reactions to the constituent food&#xD;
&#xD;
          -  Any person deemed inappropriate by the researcher for other reasons&#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>Sang Yeoup Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Integrated Research Institute for Natural Ingredients and Functional Foods</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Sang Yeoup Lee</investigator_full_name>
    <investigator_title>Professor</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/NCT03774381
org study id: 02-2018-016
nct id: NCT03774381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of a randomized, double-blind, and control-group study for the effect of oral
      ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults
Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body
      fat reduction in adults by a randomized, double-blind, and control-group study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Body fat
time frame: Change from baseline body fat at 12 weeks
description: dual energy x-ray absorptiometry (DEXA)
arm group label: Bifidobacterium breve B-3 group
arm group type: Experimental
description: 160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.
arm group label: Control group
arm group type: Placebo Comparator
description: 160 mg of placebo was orally administered per day for 12 weeks.
intervention type: Dietary Supplement
intervention name: Bifidobacterium breve B-3
description: 160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
arm group label: Bifidobacterium breve B-3 group
intervention type: Dietary Supplement
intervention name: Control group
description: 160 mg of placebo is orally administered per day for 12 weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang Yeoup Lee, MD
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Sang Yeoup Lee
investigator title: Professor