<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/NCT03248414</url>
  </required_header>
  <id_info>
    <org_study_id>B-1511/324-002</org_study_id>
    <nct_id>NCT03248414</nct_id>
  </id_info>
  <brief_title>Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects</brief_title>
  <official_title>Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction&#xD;
      of fat mass assessed by DEXA compared to plaebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned&#xD;
      study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2016</start_date>
  <completion_date type="Actual">September 10, 2018</completion_date>
  <primary_completion_date type="Actual">June 10, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fat mass change in 12-week</measure>
    <time_frame>12 weeks</time_frame>
    <description>fat mass is measured by DEXA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>body weight change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>12 weeks</time_frame>
    <description>Waist circumference change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in fasting glucose concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in insulin resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose metabolism</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in beta-cell function</description>
  </secondary_outcome>
  <other_outcome>
    <measure>GI adverse effect</measure>
    <time_frame>12 weeks</time_frame>
    <description>incidence of gastrointestinal discomfort</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lactobacillus sakei</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 packs per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 packs per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus sakei</intervention_name>
    <description>1 pack contained 5 x 109 cfu</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Lactobacillus sakei</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20-65 years&#xD;
&#xD;
          -  BMI equal to higher than 25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under anti-obesity medication&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  any medications can influence to body weight such as thiazolidinedione, GLP-1&#xD;
             analogue, SGLT2 inhibitor, diuretics&#xD;
&#xD;
          -  thyroid function test abnormality&#xD;
&#xD;
          -  malignancy within 5 years&#xD;
&#xD;
          -  immune compromised hosts or under immune suppressants&#xD;
&#xD;
          -  antibiotics or probiotics withing 2 weeks&#xD;
&#xD;
          -  any intervention to reduce body weight within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 9, 2018</last_update_submitted>
  <last_update_submitted_qc>September 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Soo Lim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03248414
org study id: B-1511/324-002
nct id: NCT03248414
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction
      of fat mass assessed by DEXA compared to plaebo.
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned
      study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double blinded
measure: Fat mass change in 12-week
time frame: 12 weeks
description: fat mass is measured by DEXA
measure: Changes in body weight
time frame: 12 weeks
description: body weight change
measure: Changes in waist circumference
time frame: 12 weeks
description: Waist circumference change
measure: Glucose metabolism
time frame: 12 weeks
description: Changes in HbA1c
measure: Glucose metabolism
time frame: 12 weeks
description: Changes in fasting glucose concentration
measure: Glucose metabolism
time frame: 12 weeks
description: Changes in insulin resistance
measure: Glucose metabolism
time frame: 12 weeks
description: Changes in beta-cell function
measure: GI adverse effect
time frame: 12 weeks
description: incidence of gastrointestinal discomfort
arm group label: Lactobacillus sakei
arm group type: Experimental
description: 2 packs per day
arm group label: Control
arm group type: Placebo Comparator
description: 2 packs per day
intervention type: Dietary Supplement
intervention name: Lactobacillus sakei
description: 1 pack contained 5 x 109 cfu
arm group label: Control
arm group label: Lactobacillus sakei
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Soo Lim
investigator title: Professor
mesh term: Obesity
sharing ipd: No