<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/NCT04496895</url>
  </required_header>
  <id_info>
    <org_study_id>201912030RSA</org_study_id>
    <nct_id>NCT04496895</nct_id>
  </id_info>
  <brief_title>The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults</brief_title>
  <official_title>The Evaluation of Orange Peel Fermentation on Body Fat 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>
    <has_dmc>No</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>
      To assess whether orange peel fermentation has the effect of reducing body fat in 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 clinical diagnosis item of overweight or fatty liver is evaluated&#xD;
      by the doctor. The questionnaires are collected at every visit of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 12, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 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>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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 creatine</description>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Overweight</condition>
  <condition>Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>consume 1 sachet per day for 2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>orange peel fermentation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>consume 1 sachet per day for 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>consume 1 sachet per day for 2 months</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>orange peel fermentation</intervention_name>
    <description>consume 1 sachet per day for 2 months</description>
    <arm_group_label>orange peel fermentation</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. For those with BMI ≥ 24 or fatty liver, 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 illness, alcohol or drug abuse, and other major organic&#xD;
             diseases (according to medical history).&#xD;
&#xD;
          2. No person who has received major surgery or bariatric surgery (according to medical&#xD;
             history).&#xD;
&#xD;
          3. I have used drugs that affect body fat, waist circumference or significantly increase&#xD;
             weight, such as systemic corticosteroids, tricyclic antidepressants, atypical&#xD;
             psychiatric drugs, and mood stability in the current or 3 months before participating&#xD;
             in the screening Drugs (according to medical history).&#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>
  <overall_official>
    <last_name>LIOU JYH-MING, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HUANG YU-JYUN</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_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 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>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT04496895
org study id: 201912030RSA
nct id: NCT04496895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess whether orange peel fermentation has the effect of reducing body fat in adults
This is a double-blind and randomized study. Subjects are informed to consume the samples
      every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated
      by the doctor. The 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 creatine
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: consume 1 sachet per day for 2 months
arm group label: orange peel fermentation
arm group type: Experimental
description: consume 1 sachet per day for 2 months
intervention type: Dietary Supplement
intervention name: Placebo
description: consume 1 sachet per day for 2 months
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: orange peel fermentation
description: consume 1 sachet per day for 2 months
arm group label: orange peel fermentation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: LIOU JYH-MING, Doctor
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: HUANG YU-JYUN
phone: 0934173838
email: nneder34@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Overweight