<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/NCT04490720</url>
  </required_header>
  <id_info>
    <org_study_id>201911003RSC</org_study_id>
    <nct_id>NCT04490720</nct_id>
  </id_info>
  <brief_title>The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors</brief_title>
  <official_title>The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors</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 efficacy evaluation of buckwheat husk extract on cardiovascular disease risk&#xD;
      factors&#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 cardiovascular disease is evaluated by&#xD;
      the doctor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 24, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)</measure>
    <time_frame>Days 1, 28, and 56</time_frame>
    <description>Blood pressure will be measured at the beginning, 4-week, and 8-week time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Body Mass Index (BMI)</measure>
    <time_frame>Days 1, 28, and 56</time_frame>
    <description>Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points.&#xD;
P.S. weight in kilograms, height in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in waist-hip ratio</measure>
    <time_frame>Days 1, 28, and 56</time_frame>
    <description>Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)</measure>
    <time_frame>Days 1, 28, and 56</time_frame>
    <description>Blood lipid will be measured at the beginning, 4-week, and 8-week time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)</measure>
    <time_frame>Days 1, 28, and 56</time_frame>
    <description>Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cardiovascular Diseases</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>Buckwheat husk extract</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>Buckwheat husk extract</intervention_name>
    <description>consume 1 sachet per day for 2 months</description>
    <arm_group_label>Buckwheat husk extract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's&#xD;
             consent.&#xD;
&#xD;
          2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is&#xD;
             between 81-89 mmHg.&#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 organ transplantation, epilepsy or convulsions, liver or kidney disease,&#xD;
             malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other&#xD;
             major organic diseases (according to medical history).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women.&#xD;
&#xD;
          2. People with a history of organ transplantation, epilepsy or convulsions, liver and&#xD;
             kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug&#xD;
             abuse, and other major organic diseases (according to medical history).&#xD;
&#xD;
          3. No person has undergone major surgery.&#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>Mao-Hsin Lin, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shyr-Chyr Chen</last_name>
    <phone>(02) 23123456</phone>
    <email>scchen@ntu.edu.tw</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>
      <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 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 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>Cardiovascular Diseases</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/NCT04490720
org study id: 201911003RSC
nct id: NCT04490720
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk
      factors
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 cardiovascular disease is evaluated by
      the doctor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
time frame: Days 1, 28, and 56
description: Blood pressure will be measured at the beginning, 4-week, and 8-week time points.
measure: Change from baseline in Body Mass Index (BMI)
time frame: Days 1, 28, and 56
description: Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points.
P.S. weight in kilograms, height in meters
measure: Change from baseline in waist-hip ratio
time frame: Days 1, 28, and 56
description: Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.
measure: Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
time frame: Days 1, 28, and 56
description: Blood lipid will be measured at the beginning, 4-week, and 8-week time points.
measure: Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)
time frame: Days 1, 28, and 56
description: Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.
arm group label: Placebo
arm group type: Placebo Comparator
description: consume 1 sachet per day for 2 months
arm group label: Buckwheat husk extract
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: Buckwheat husk extract
description: consume 1 sachet per day for 2 months
arm group label: Buckwheat husk extract
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mao-Hsin Lin, Doctor
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Shyr-Chyr Chen
phone: (02) 23123456
email: scchen@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cardiovascular Diseases