<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/NCT01724645</url>
  </required_header>
  <id_info>
    <org_study_id>CUH_KOREAN-FOOD_2-2_2010</org_study_id>
    <nct_id>NCT01724645</nct_id>
  </id_info>
  <brief_title>Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes</brief_title>
  <official_title>Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is being conducted to look for following changes when Korean traditional diets is&#xD;
      taken in subjects with hypertension and type 2 diabetes:&#xD;
&#xD;
      To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.&#xD;
&#xD;
      To assess the controlling blood pressure and heart rate.&#xD;
&#xD;
      To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High&#xD;
      Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.&#xD;
&#xD;
      To evaluate the influence on Gamma-Glutamyl Transpeptidase.&#xD;
&#xD;
      To evaluate the influence on Cardiovascular risk factor.&#xD;
&#xD;
      To evaluate the influence on valsava score, breathing score and upright score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aimed to investigate the efficacy of Korean traditional diets in&#xD;
      controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk&#xD;
      factors in hypertensive and type 2 diabetic patients who were taking medications prescribed&#xD;
      for respective diseases in a 12-week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1C :Glycated Hemoglobin</measure>
    <time_frame>84days</time_frame>
    <description>Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TG :Triglycerides</measure>
    <time_frame>84days</time_frame>
    <description>Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TC :Total cholesterol</measure>
    <time_frame>84days</time_frame>
    <description>Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C :High Density Lipoprotein-Cholesterol</measure>
    <time_frame>84days</time_frame>
    <description>HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C : Low Density Lipoprotein-Cholesterol</measure>
    <time_frame>84days</time_frame>
    <description>LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breathing score</measure>
    <time_frame>84days</time_frame>
    <description>Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valsalva score</measure>
    <time_frame>84days</time_frame>
    <description>Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upright score</measure>
    <time_frame>84days</time_frame>
    <description>Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoA1 :Apolipoprotein A1</measure>
    <time_frame>84days</time_frame>
    <description>Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoB :Apolipoprotein B</measure>
    <time_frame>84days</time_frame>
    <description>Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apo E :Apolipoprotein E</measure>
    <time_frame>84days</time_frame>
    <description>Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free fatty acid</measure>
    <time_frame>84days</time_frame>
    <description>Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>84days</time_frame>
    <description>Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAI-1 :Plasminogen activator inhibitor type 1</measure>
    <time_frame>84days</time_frame>
    <description>PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homocysteine</measure>
    <time_frame>84days</time_frame>
    <description>Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FPG :Fasting plasma glucose</measure>
    <time_frame>84days</time_frame>
    <description>Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBP:Diastolic Blood Pressure</measure>
    <time_frame>84days</time_frame>
    <description>DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SBP:Systolic Blood Pressure</measure>
    <time_frame>84days</time_frame>
    <description>SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>84days</time_frame>
    <description>Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>weight</measure>
    <time_frame>84days</time_frame>
    <description>weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI:Body Mass Index</measure>
    <time_frame>84days</time_frame>
    <description>BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body fat percent</measure>
    <time_frame>84days</time_frame>
    <description>Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist</measure>
    <time_frame>84days</time_frame>
    <description>Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Obesity associated gut microbiome(Bacteriodetes)</measure>
    <time_frame>84days</time_frame>
    <description>Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Obesity associated gut microbiome(Firmicutes)</measure>
    <time_frame>84days</time_frame>
    <description>Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypoglycemic(oral medication)</measure>
    <time_frame>84days</time_frame>
    <description>Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.</description>
  </other_outcome>
  <other_outcome>
    <measure>Control blood pressure(oral medication)</measure>
    <time_frame>84days</time_frame>
    <description>Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid modifying (oral medication)</measure>
    <time_frame>84days</time_frame>
    <description>Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Korean traditional diets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Korean traditional diets (calorie 2,100kcal) for 12weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group : told to &quot;eat as usal diet) for 12weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Korean traditional diets</intervention_name>
    <description>The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.&#xD;
The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.</description>
    <arm_group_label>Korean traditional diets</arm_group_label>
    <other_name>The Korean Traditonal diets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Told to &quot; eat as usal diets&quot;.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Control diets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are men and women volunteers 19~80years&#xD;
&#xD;
          -  Subject who have hypertension and type 2diabetes.&#xD;
&#xD;
          -  Subject who have taking oral medications :&#xD;
&#xD;
        (hypoglycemic, blood pressure and lipid modifying drugs).&#xD;
&#xD;
          -  Subject must provide written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with a history or evidence of clinically significant&#xD;
             gastrointestinal,anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood&#xD;
             tumor,psychiatric.&#xD;
&#xD;
          -  Hypertension(DBP&gt;116mmHg or SBP&gt;200 mmHg) having the history of cardiovascular events&#xD;
             or taking medications known to affect lipoprotein metabolism.&#xD;
&#xD;
          -  Having Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (HbA1c&#xD;
             &gt;9.0%).&#xD;
&#xD;
          -  Subjects with the history of cancer.&#xD;
&#xD;
          -  Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would&#xD;
             increase the influence with absorbance medication or a GI surgery excluding&#xD;
             appendectomy and hernia surgery.&#xD;
&#xD;
          -  Having digestive, or central nervous system disorders.&#xD;
&#xD;
          -  Subject is hematologic, or neuroretinopathy.&#xD;
&#xD;
          -  Subject with uterine fibroids at ultrasonography.&#xD;
&#xD;
          -  Having severe or malignant retinopathy.&#xD;
&#xD;
          -  Having the impairment of renal and liver function, dysproteinemia, nephritic syndrome,&#xD;
             or other renal disease.&#xD;
&#xD;
          -  Having coagulopathy&#xD;
&#xD;
          -  Having human immunodeficiency virus.&#xD;
&#xD;
          -  Having the history of mental instability and of drug and alcohol.&#xD;
&#xD;
          -  Having the history of reactions to our experimental products.&#xD;
&#xD;
          -  Participating in other clinical trials within the past 2 months.&#xD;
&#xD;
          -  Having laboratory tests, medical or psychological conditions deemed by the&#xD;
             investigators to interfere with successful participation in the study.&#xD;
&#xD;
          -  Having the history of alcohol or substance abuse.&#xD;
&#xD;
          -  Subject is pregnant, planning to become pregnant, or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soo-Wan Chae, MD., PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods; Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>560-822</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</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>director</investigator_title>
  </responsible_party>
  <keyword>Korean Traditional diets</keyword>
  <keyword>hypertension</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 18, 2012</submitted>
    <returned>December 13, 2012</returned>
    <submitted>July 29, 2013</submitted>
    <returned>September 26, 2013</returned>
    <submitted>August 28, 2019</submitted>
    <returned>September 26, 2019</returned>
    <submitted>September 27, 2019</submitted>
    <returned>October 18, 2019</returned>
    <submitted>October 22, 2019</submitted>
    <returned>November 8, 2019</returned>
    <submitted>December 17, 2019</submitted>
    <returned>January 3, 2020</returned>
  </pending_results>
  <!-- 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/NCT01724645
org study id: CUH_KOREAN-FOOD_2-2_2010
nct id: NCT01724645
lead sponsor: 
has dmc: Yes
This trial is being conducted to look for following changes when Korean traditional diets is
      taken in subjects with hypertension and type 2 diabetes:

      To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.

      To assess the controlling blood pressure and heart rate.

      To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High
      Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.

      To evaluate the influence on Gamma-Glutamyl Transpeptidase.

      To evaluate the influence on Cardiovascular risk factor.

      To evaluate the influence on valsava score, breathing score and upright score.
The investigators aimed to investigate the efficacy of Korean traditional diets in
      controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk
      factors in hypertensive and type 2 diabetic patients who were taking medications prescribed
      for respective diseases in a 12-week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HbA1C :Glycated Hemoglobin
time frame: 84days
description: Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: TG :Triglycerides
time frame: 84days
description: Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: TC :Total cholesterol
time frame: 84days
description: Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: HDL-C :High Density Lipoprotein-Cholesterol
time frame: 84days
description: HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: LDL-C : Low Density Lipoprotein-Cholesterol
time frame: 84days
description: LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Breathing score
time frame: 84days
description: Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
measure: Valsalva score
time frame: 84days
description: Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
measure: Upright score
time frame: 84days
description: Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
measure: ApoA1 :Apolipoprotein A1
time frame: 84days
description: Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: ApoB :Apolipoprotein B
time frame: 84days
description: Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Apo E :Apolipoprotein E
time frame: 84days
description: Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Free fatty acid
time frame: 84days
description: Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Adiponectin
time frame: 84days
description: Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: PAI-1 :Plasminogen activator inhibitor type 1
time frame: 84days
description: PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Homocysteine
time frame: 84days
description: Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: FPG :Fasting plasma glucose
time frame: 84days
description: Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: DBP:Diastolic Blood Pressure
time frame: 84days
description: DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: SBP:Systolic Blood Pressure
time frame: 84days
description: SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Heart rate
time frame: 84days
description: Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: weight
time frame: 84days
description: weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: BMI:Body Mass Index
time frame: 84days
description: BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Body fat percent
time frame: 84days
description: Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Waist
time frame: 84days
description: Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
measure: Obesity associated gut microbiome(Bacteriodetes)
time frame: 84days
description: Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
measure: Obesity associated gut microbiome(Firmicutes)
time frame: 84days
description: Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
measure: Hypoglycemic(oral medication)
time frame: 84days
description: Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
measure: Control blood pressure(oral medication)
time frame: 84days
description: Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
measure: Lipid modifying (oral medication)
time frame: 84days
description: Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
arm group label: Korean traditional diets
arm group type: Experimental
description: Korean traditional diets (calorie 2,100kcal) for 12weeks
arm group label: Control group
arm group type: Active Comparator
description: Control group : told to "eat as usal diet) for 12weeks
intervention type: Dietary Supplement
intervention name: Korean traditional diets
description: The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.
The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.
arm group label: Korean traditional diets
other name: The Korean Traditonal diets
intervention type: Dietary Supplement
intervention name: Control group
description: Told to " eat as usal diets".
arm group label: Control group
other name: Control diets
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Soo-Wan Chae, MD., PhD
role: Study Director
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: director
mesh term: Hypertension
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
submitted: November 18, 2012
returned: December 13, 2012
submitted: July 29, 2013
returned: September 26, 2013
submitted: August 28, 2019
returned: September 26, 2019
submitted: September 27, 2019
returned: October 18, 2019
submitted: October 22, 2019
returned: November 8, 2019
submitted: December 17, 2019
returned: January 3, 2020