<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/NCT01699074</url>
  </required_header>
  <id_info>
    <org_study_id>182629</org_study_id>
    <nct_id>NCT01699074</nct_id>
  </id_info>
  <brief_title>Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes</brief_title>
  <acronym>KWG</acronym>
  <official_title>Acute Dose Response Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Cardiovascular Disease Risk Factors in Individuals With Metabolic Syndrome or Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <brief_summary>
    <textblock>
      The study is a Phase-I like double blind randomized placebo controlled crossover design&#xD;
      trial. The objective is to assess the dose response relationship on glycemic and vascular&#xD;
      effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in&#xD;
      individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2&#xD;
      Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:&#xD;
      as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be&#xD;
      recruited for the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study hypothesizes that KWG will dose dependently lower postprandial area under the&#xD;
      curve compared to negative control, as well as will dose dependently decrease postprandial&#xD;
      glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial&#xD;
      blood pressure, aortic augmentation index, and mean arterial pressure, and improve left&#xD;
      ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to&#xD;
      control. Finally, it expects to notice an effect on subjective satiety levels and have no&#xD;
      significant adverse effects compared to control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of KWG on vascular and glycemic measures</measure>
    <time_frame>3 hours</time_frame>
    <description>To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of KWG on vascular and glycemic measures</measure>
    <time_frame>4 hours</time_frame>
    <description>To evaluate the acute effect of Korean White ginseng treatments on peak and postprandial glycemia measures.To evaluate the acute effect of KWG treatments on aortic and brachial blood pressure To evaluate the acute effect of KWG treatments on heart rate, mean arterial pressure, left ventricular ejection duration (ED) and subendocardial viability ratio (SEVR) - a surrogate marker of myocardial perfusion</description>
  </secondary_outcome>
  <other_outcome>
    <measure>KWG and satiety</measure>
    <time_frame>4 hours</time_frame>
    <description>To evaluate the acute effect of KWG treatments on subjective satiety scores to determine any potential effects on appetite control mechanisms compared to controls. Symptoms questionnaire will assess potential adverse effects of treatments (safety)</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>1 gram of White Korean Ginseng</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 gram of White Korean Ginseng</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 grams of White Korean Ginseng</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 grams of White Korean Ginseng</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 grams of White Korean Ginseng</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 grams of White Korean Ginseng</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 grams of Wheat Bran Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 grams of Wheat Bran Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>500mg of Korean Red Ginseng</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>500mg of Korean Red Ginseng</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>1 gram of White Korean Ginseng</intervention_name>
    <description>1 gram of White Korean Ginseng</description>
    <arm_group_label>1 gram of White Korean Ginseng</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>3 grams of White Korean Ginseng</intervention_name>
    <description>3 grams of White Korean Ginseng</description>
    <arm_group_label>3 grams of White Korean Ginseng</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>6 grams of White Korean Ginseng</intervention_name>
    <description>6 grams of White Korean Ginseng</description>
    <arm_group_label>6 grams of White Korean Ginseng</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>3 grams of Wheat Bran Control</intervention_name>
    <description>3 grams of Wheat Bran Control</description>
    <arm_group_label>3 grams of Wheat Bran Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>500mg of Korean Red Ginseng</intervention_name>
    <description>500mg of Korean Red Ginseng</description>
    <arm_group_label>500mg of Korean Red Ginseng</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  18-75 years old&#xD;
&#xD;
          -  BMI 25-35 kg/m2&#xD;
&#xD;
          -  Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral&#xD;
             hypoglycemic medication) OR&#xD;
&#xD;
          -  Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education&#xD;
             Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three&#xD;
             of the following must be present:&#xD;
&#xD;
          -  central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36&#xD;
             inches(female)&#xD;
&#xD;
          -  dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl);&#xD;
&#xD;
          -  dyslipidemia: HDL-C &lt; 40 mg/dL (male), &lt; 50 mg/dL (female) blood pressure ≥ 130/85&#xD;
             mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;35 kg/m2&#xD;
&#xD;
          -  Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)&#xD;
&#xD;
          -  Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the&#xD;
             study.&#xD;
&#xD;
          -  Women of childbearing age that do not use acceptable method of birth control (ie.&#xD;
             abstinence, implants, injectables, oral contraceptives, IUDs etc).&#xD;
&#xD;
          -  Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding&#xD;
             disorders, history of angina, congestive heart failure, coronary revascularization,&#xD;
             peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular&#xD;
             event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors,&#xD;
             medications affecting NO synthesis (eg. Viagra)&#xD;
&#xD;
          -  Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the&#xD;
             capsules.&#xD;
&#xD;
          -  Use of any ginseng products within three days preceding the study and during the&#xD;
             study.&#xD;
&#xD;
          -  Allergies to Panax species, their constituents or to other members of the Araliaceae&#xD;
             family.&#xD;
&#xD;
        The use of additional NHPs that may affect blood pressure or blood glucose Individuals&#xD;
        suffering from glucose-galactose malabsorption syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Korean White Ginseng</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Metabolic syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT01699074
org study id: 182629
nct id: NCT01699074
lead sponsor: 
The study is a Phase-I like double blind randomized placebo controlled crossover design
      trial. The objective is to assess the dose response relationship on glycemic and vascular
      effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in
      individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2
      Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:
      as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be
      recruited for the study.
This study hypothesizes that KWG will dose dependently lower postprandial area under the
      curve compared to negative control, as well as will dose dependently decrease postprandial
      glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial
      blood pressure, aortic augmentation index, and mean arterial pressure, and improve left
      ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to
      control. Finally, it expects to notice an effect on subjective satiety levels and have no
      significant adverse effects compared to control.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Effect of KWG on vascular and glycemic measures
time frame: 3 hours
description: To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx)
measure: Effect of KWG on vascular and glycemic measures
time frame: 4 hours
description: To evaluate the acute effect of Korean White ginseng treatments on peak and postprandial glycemia measures.To evaluate the acute effect of KWG treatments on aortic and brachial blood pressure To evaluate the acute effect of KWG treatments on heart rate, mean arterial pressure, left ventricular ejection duration (ED) and subendocardial viability ratio (SEVR) - a surrogate marker of myocardial perfusion
measure: KWG and satiety
time frame: 4 hours
description: To evaluate the acute effect of KWG treatments on subjective satiety scores to determine any potential effects on appetite control mechanisms compared to controls. Symptoms questionnaire will assess potential adverse effects of treatments (safety)
arm group label: 1 gram of White Korean Ginseng
arm group type: Experimental
description: 1 gram of White Korean Ginseng
arm group label: 3 grams of White Korean Ginseng
arm group type: Experimental
description: 3 grams of White Korean Ginseng
arm group label: 6 grams of White Korean Ginseng
arm group type: Experimental
description: 6 grams of White Korean Ginseng
arm group label: 3 grams of Wheat Bran Control
arm group type: Placebo Comparator
description: 3 grams of Wheat Bran Control
arm group label: 500mg of Korean Red Ginseng
arm group type: Active Comparator
description: 500mg of Korean Red Ginseng
intervention type: Dietary Supplement
intervention name: 1 gram of White Korean Ginseng
description: 1 gram of White Korean Ginseng
arm group label: 1 gram of White Korean Ginseng
intervention type: Dietary Supplement
intervention name: 3 grams of White Korean Ginseng
description: 3 grams of White Korean Ginseng
arm group label: 3 grams of White Korean Ginseng
intervention type: Dietary Supplement
intervention name: 6 grams of White Korean Ginseng
description: 6 grams of White Korean Ginseng
arm group label: 6 grams of White Korean Ginseng
intervention type: Dietary Supplement
intervention name: 3 grams of Wheat Bran Control
description: 3 grams of Wheat Bran Control
arm group label: 3 grams of Wheat Bran Control
intervention type: Dietary Supplement
intervention name: 500mg of Korean Red Ginseng
description: 500mg of Korean Red Ginseng
arm group label: 500mg of Korean Red Ginseng
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metabolic Syndrome
mesh term: Syndrome