<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/NCT04492605</url>
  </required_header>
  <id_info>
    <org_study_id>201912029RSA</org_study_id>
    <nct_id>NCT04492605</nct_id>
  </id_info>
  <brief_title>The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults</brief_title>
  <official_title>The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TCI Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TCI Co., Ltd.</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>
      To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in&#xD;
      adults&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind and randomized study. Subjects are informed to consume the samples&#xD;
      every day for 2 months. The person who is evaluated as overweight by the doctor will be&#xD;
      invited to participate in this trial. The efficacy assessment items and questionnaires are&#xD;
      collected at every visit of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 9, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>The change of body fat mass</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>The body fat mass (kg) was assessed by InBody770</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of Triglyceride</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of Triglyceride</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of Total cholestrol</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of Total cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of HDL-cholestrol</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of HDL-cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of LDL-cholestrol</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of LDL-cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of body mass index (BMI)</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of body fat percentage</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>The body fat percentage (%) was assessed by InBody770.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of visceral fat</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>The visceral fat (10 cm^2) was assessed by InBody770.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of fasting glycemia</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of fasting glycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of aspartate aminotransferase</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of aspartate aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of alanine aminotransferase</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of alanine aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of albumin</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of creatine</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of creatine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of uric acid</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of white blood cell</measure>
    <time_frame>Weeks 0, 4 and 8</time_frame>
    <description>Venous blood was sampled to measure concentrations of white blood cell</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TCI378 Probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TCI378 Probiotics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TCI507 Probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TCI507 Probiotics</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>consume 1 capsule per day for 2 months</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>TCI378 Probiotics</intervention_name>
    <description>consume 1 capsule per day for 2 months</description>
    <arm_group_label>TCI378 Probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>TCI507 Probiotics</intervention_name>
    <description>consume 1 capsule per day for 2 months</description>
    <arm_group_label>TCI507 Probiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the&#xD;
             subject.&#xD;
&#xD;
          2. BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.&#xD;
&#xD;
          3. Those who are not pregnant and are willing to cooperate with contraception during the&#xD;
             trial period.&#xD;
&#xD;
          4. No history of cardiovascular disease, history of organ transplantation, history of&#xD;
             epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease,&#xD;
             mental disease, alcohol or drug abuse, or other major organic diseases (according to&#xD;
             medical history).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women, people with a history of cardiovascular disease, organ&#xD;
             transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors,&#xD;
             endocrine diseases, mental diseases, alcohol or drug abuse, and other major organic&#xD;
             diseases (according to medical history).&#xD;
&#xD;
          2. No person who has undergone major surgery or bariatric surgery (according to medical&#xD;
             history).&#xD;
&#xD;
          3. Drugs that affect body fat, waist circumference, or significantly increase weight,&#xD;
             such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric&#xD;
             drugs, and mood stability, have been used at present or within 3 months before&#xD;
             participating in the screening Drugs (according to medical history).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LIOU JYH-MING</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hung YU-JUN</last_name>
    <phone>0934173838</phone>
    <email>nneder34@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>chi fu chiang, Ph.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>chi fu chiang, phd</last_name>
      <email>Jimmy.Chiang@tci-bio.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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/NCT04492605
org study id: 201912029RSA
nct id: NCT04492605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in
      adults
This is a double-blind and randomized study. Subjects are informed to consume the samples
      every day for 2 months. The person who is evaluated as overweight by the doctor will be
      invited to participate in this trial. The efficacy assessment items and questionnaires are
      collected at every visit of the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The change of body fat mass
time frame: Weeks 0, 4 and 8
description: The body fat mass (kg) was assessed by InBody770
measure: The change of Triglyceride
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of Triglyceride
measure: The change of Total cholestrol
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of Total cholestrol
measure: The change of HDL-cholestrol
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of HDL-cholestrol
measure: The change of LDL-cholestrol
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of LDL-cholestrol
measure: The change of body mass index (BMI)
time frame: Weeks 0, 4 and 8
description: BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
measure: The change of body fat percentage
time frame: Weeks 0, 4 and 8
description: The body fat percentage (%) was assessed by InBody770.
measure: The change of visceral fat
time frame: Weeks 0, 4 and 8
description: The visceral fat (10 cm^2) was assessed by InBody770.
measure: The change of fasting glycemia
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of fasting glycemia
measure: The change of aspartate aminotransferase
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of aspartate aminotransferase
measure: The change of alanine aminotransferase
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of alanine aminotransferase
measure: The change of albumin
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of albumin
measure: The change of creatine
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of creatine
measure: The change of uric acid
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of uric acid
measure: The change of white blood cell
time frame: Weeks 0, 4 and 8
description: Venous blood was sampled to measure concentrations of white blood cell
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: TCI378 Probiotics
arm group type: Experimental
description: TCI378 Probiotics
arm group label: TCI507 Probiotics
arm group type: Experimental
description: TCI507 Probiotics
intervention type: Dietary Supplement
intervention name: Placebo
description: consume 1 capsule per day for 2 months
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: TCI378 Probiotics
description: consume 1 capsule per day for 2 months
arm group label: TCI378 Probiotics
intervention type: Dietary Supplement
intervention name: TCI507 Probiotics
description: consume 1 capsule per day for 2 months
arm group label: TCI507 Probiotics
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: LIOU JYH-MING
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Hung YU-JUN
phone: 0934173838
email: nneder34@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No