<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/NCT03807570</url>
  </required_header>
  <id_info>
    <org_study_id>BA-BF-MBE</org_study_id>
    <nct_id>NCT03807570</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow</brief_title>
  <official_title>A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonbuk National University Hospital</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>
      The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related&#xD;
      indicators is assessed compared to placebo intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred&#xD;
      subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was&#xD;
      collected and changes in blood circulation related indicators were observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Reactive Hyperemia Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Platelet function assay</measure>
    <time_frame>12 weeks</time_frame>
    <description>The whole blood with anticoagulant (sodium citrate) is passed through the capillary and the membrane to assess the degree of platelet adhesion to this membrane and the degree of occlusion of the capillary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of blood flow indices: PAI-1, t-PA</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood flow indices(PAI-1, t-PA) were measured in study visit 1(0 week) and visit 3(12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Pulse wave</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured using a pulse wave measuring device (uBioClipTM; BiosenseCreative Co., Ltd., Seoul, Korea) and measured three times, the average value of the measured values is indicated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Oxidation stress index: Oxidized LDL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Oxidation stress indices(Oxidized LDL) was measured in study visit 1(0 week) and visit 3(12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Lipid peroxidation index: MDA (Malondialdehyde)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Lipid peroxidation index{MDA(Malondialdehyde)} was measured in study visit 1(0 week) and visit 3(12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Lipid metabolism indices(Total cholesterol, Triglyceride, LDL-C, HDL-C) were measured in study screening and visit 3(12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C</measure>
    <time_frame>12 weeks</time_frame>
    <description>It is calculated by the calculation formula using the lipid metabolism indicator test item.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Blood Flow</condition>
  <arm_group>
    <arm_group_label>Morus Alba L. extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Morus Alba L. extract 30 ml/day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 30 ml/day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Morus Alba L. Extract</intervention_name>
    <description>Morus Alba L. Extract 30 ml/day for 12 weeks.</description>
    <arm_group_label>Morus Alba L. extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 30 ml/day for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those with a fasting total cholesterol of 200~239 mg/dL&#xD;
&#xD;
          -  Those with a fasting LDL-cholesterol of 130~159 mg/dL&#xD;
&#xD;
          -  Those with a fasting blood sugar of 100~125 mg/dL&#xD;
&#xD;
          -  Those with a SBP of 120~139 mmHg&#xD;
&#xD;
          -  Those with a BMI of 25~29.9 kg/m^2&#xD;
&#xD;
          -  Waist Hip Ratio (WHR) is 0.9 or more for males and 0.85 or more for females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with platelet aggregation and significant disability&#xD;
&#xD;
               -  The platelet count is less than 100,000/μL or more than 500,000/μL&#xD;
&#xD;
               -  The Hematocrit is less than 25%&#xD;
&#xD;
          -  BMI is less than 18.5kg/m^2 or greater than 30kg/m^2&#xD;
&#xD;
          -  Those with clinically significant severe cardiovascular, endocrine, immune,&#xD;
             respiratory, liver, biliary, renal and urinary tract, neuropsychiatry,&#xD;
             musculoskeletal, inflammatory and hematologic and gastrointestinal disorders&#xD;
&#xD;
          -  Those with a history of clinically significant hypersensitivity to mulberry&#xD;
&#xD;
          -  Those who have been taking platelet function, blood circulation improvement and&#xD;
             hyperlipidemia related medicines, health functional food or herbal medicine&#xD;
             continuously for more than 7 days within one month before screening&#xD;
&#xD;
          -  Those who have received antipsychotic medication within 2 months before screening&#xD;
&#xD;
          -  Those who participated in other clinical trials within 3 months before screening&#xD;
&#xD;
          -  Women receiving hormone replacement therapy&#xD;
&#xD;
          -  Laboratory test by show the following results&#xD;
&#xD;
               -  AST, ALT &gt; Reference range 3 times upper limit&#xD;
&#xD;
               -  Serum Creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Those who doesn't accept the implementation of appropriate contraception of a&#xD;
             childbearing woman&#xD;
&#xD;
          -  Principal Investigator judged inappropriate for participation in study because of&#xD;
             Laboratory test result, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Soo Wan Chae, Ph.D., M.D.</last_name>
    <phone>82-63-259-3040</phone>
    <email>soowan@jbnu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Soo-Wan Chae, MD., PhD</last_name>
      <phone>82-63-259-3040</phone>
      <email>swchae@jbctc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-Wan Chae</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <keyword>Morus Alba L. Extract</keyword>
  <keyword>Clinical Trial</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/NCT03807570
org study id: BA-BF-MBE
nct id: NCT03807570
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related
      indicators is assessed compared to placebo intake.
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred
      subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was
      collected and changes in blood circulation related indicators were observed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of Reactive Hyperemia Index
time frame: 12 weeks
description: Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).
measure: Changes of Platelet function assay
time frame: 12 weeks
description: The whole blood with anticoagulant (sodium citrate) is passed through the capillary and the membrane to assess the degree of platelet adhesion to this membrane and the degree of occlusion of the capillary.
measure: Changes of blood flow indices: PAI-1, t-PA
time frame: 12 weeks
description: Blood flow indices(PAI-1, t-PA) were measured in study visit 1(0 week) and visit 3(12 weeks).
measure: Changes of Pulse wave
time frame: 12 weeks
description: Measured using a pulse wave measuring device (uBioClipTM; BiosenseCreative Co., Ltd., Seoul, Korea) and measured three times, the average value of the measured values is indicated.
measure: Changes of Oxidation stress index: Oxidized LDL
time frame: 12 weeks
description: Oxidation stress indices(Oxidized LDL) was measured in study visit 1(0 week) and visit 3(12 weeks).
measure: Changes of Lipid peroxidation index: MDA (Malondialdehyde)
time frame: 12 weeks
description: Lipid peroxidation index{MDA(Malondialdehyde)} was measured in study visit 1(0 week) and visit 3(12 weeks).
measure: Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C
time frame: 12 weeks
description: Lipid metabolism indices(Total cholesterol, Triglyceride, LDL-C, HDL-C) were measured in study screening and visit 3(12 weeks).
measure: Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C
time frame: 12 weeks
description: It is calculated by the calculation formula using the lipid metabolism indicator test item.
arm group label: Morus Alba L. extract
arm group type: Experimental
description: Morus Alba L. extract 30 ml/day for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 30 ml/day for 12 weeks
intervention type: Dietary Supplement
intervention name: Morus Alba L. Extract
description: Morus Alba L. Extract 30 ml/day for 12 weeks.
arm group label: Morus Alba L. extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo 30 ml/day for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soo Wan Chae, Ph.D., M.D.
phone: 82-63-259-3040
email: soowan@jbnu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal Investigator, Clinical Trial Center for Functional Foods