<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/NCT04501601</url>
  </required_header>
  <id_info>
    <org_study_id>20-039-A</org_study_id>
    <nct_id>NCT04501601</nct_id>
  </id_info>
  <brief_title>The Effect of Consuming on Body Composition and Blood Biochemistry Index</brief_title>
  <official_title>The Effect of Consuming on Body Composition and Blood Biochemistry Index</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 effect of consuming on body composition and blood biochemistry index&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of body fat mass</measure>
    <time_frame>Change from Baseline body fat mass at 2 months</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>Change from Baseline triglyceride at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of Triglyceride</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of Total cholesterol</measure>
    <time_frame>Change from Baseline total cholesterol at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of Total cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of HDL-cholesterol</measure>
    <time_frame>Change from Baseline HDL-cholesterol at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of HDL-cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of LDL-cholesterol</measure>
    <time_frame>Change from Baseline LDL-cholesterol at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of LDL-cholestrol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal microbiome analysis</measure>
    <time_frame>Change from Baseline Fecal microbiome at 2 months</time_frame>
    <description>Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of body mass index (BMI)</measure>
    <time_frame>Change from Baseline body mass index at 2 months</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>Change from Baseline body fat percentage at 2 months</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>Change from Baseline visceral fat at 2 months</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>Change from Baseline fasting glycemia at 2 months</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>Change from Baseline aspartate aminotransferase at 2 months</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>Change from Baseline alanine aminotransferase at 2 months</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>Change from Baseline albumin at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of creatinine</measure>
    <time_frame>Change from Baseline creatinine at 2 months</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>Change from Baseline uric acid at 2 months</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>Change from Baseline white blood cell at 2 months</time_frame>
    <description>Venous blood was sampled to measure concentrations of white blood cell</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Gut Microbiota</condition>
  <arm_group>
    <arm_group_label>Experimental: weight loss program kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>weight loss program kit</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fruit and vegetable solid drink</intervention_name>
    <description>weight loss program supplement</description>
    <arm_group_label>Experimental: weight loss program kit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged between 20 and 60 years old&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass: male &gt; 25%, female &gt; 30%&#xD;
&#xD;
          -  Prohibitions on other nutritional supplements (probiotics and prebiotics) before two&#xD;
             weeks of the study&#xD;
&#xD;
          -  Abidance by the similar diet and exercise habits over the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Menopausal woman&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Implementation in weight loss programs before a half year of this study&#xD;
&#xD;
          -  Metabolic disorders&#xD;
&#xD;
          -  Kidney diseases&#xD;
&#xD;
          -  Liver diseases&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
&#xD;
          -  Nervous system diseases&#xD;
&#xD;
          -  Gastrointestinal diseases&#xD;
&#xD;
          -  Heavy drinking or constant drug use.&#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>Bo-Han Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Pingtung University of Science and Technology</name>
      <address>
        <city>Pingtung</city>
        <state>Neipu Township</state>
        <zip>91201</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anthropometric index</keyword>
  <keyword>Biochemical items</keyword>
  <!-- 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/NCT04501601
org study id: 20-039-A
nct id: NCT04501601
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess the effect of consuming on body composition and blood biochemistry index
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The change of body fat mass
time frame: Change from Baseline body fat mass at 2 months
description: The body fat mass (kg) was assessed by InBody770.
measure: The change of Triglyceride
time frame: Change from Baseline triglyceride at 2 months
description: Venous blood was sampled to measure concentrations of Triglyceride
measure: The change of Total cholesterol
time frame: Change from Baseline total cholesterol at 2 months
description: Venous blood was sampled to measure concentrations of Total cholestrol
measure: The change of HDL-cholesterol
time frame: Change from Baseline HDL-cholesterol at 2 months
description: Venous blood was sampled to measure concentrations of HDL-cholestrol
measure: The change of LDL-cholesterol
time frame: Change from Baseline LDL-cholesterol at 2 months
description: Venous blood was sampled to measure concentrations of LDL-cholestrol
measure: Fecal microbiome analysis
time frame: Change from Baseline Fecal microbiome at 2 months
description: Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.
measure: The change of body mass index (BMI)
time frame: Change from Baseline body mass index at 2 months
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: Change from Baseline body fat percentage at 2 months
description: The body fat percentage (%) was assessed by InBody770
measure: The change of visceral fat
time frame: Change from Baseline visceral fat at 2 months
description: The visceral fat (10 cm^2) was assessed by InBody770.
measure: The change of fasting glycemia
time frame: Change from Baseline fasting glycemia at 2 months
description: Venous blood was sampled to measure concentrations of fasting glycemia
measure: The change of aspartate aminotransferase
time frame: Change from Baseline aspartate aminotransferase at 2 months
description: Venous blood was sampled to measure concentrations of aspartate aminotransferase
measure: The change of alanine aminotransferase
time frame: Change from Baseline alanine aminotransferase at 2 months
description: Venous blood was sampled to measure concentrations of alanine aminotransferase
measure: The change of albumin
time frame: Change from Baseline albumin at 2 months
description: Venous blood was sampled to measure concentrations of albumin
measure: The change of creatinine
time frame: Change from Baseline creatinine at 2 months
description: Venous blood was sampled to measure concentrations of creatine
measure: The change of uric acid
time frame: Change from Baseline uric acid at 2 months
description: Venous blood was sampled to measure concentrations of uric acid
measure: The change of white blood cell
time frame: Change from Baseline white blood cell at 2 months
description: Venous blood was sampled to measure concentrations of white blood cell
arm group label: Experimental: weight loss program kit
arm group type: Experimental
description: weight loss program kit
intervention type: Dietary Supplement
intervention name: Fruit and vegetable solid drink
description: weight loss program supplement
arm group label: Experimental: weight loss program kit
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bo-Han Wu
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: Taiwan
responsible party type: Sponsor