<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/NCT02254317</url>
  </required_header>
  <id_info>
    <org_study_id>2014-074</org_study_id>
    <nct_id>NCT02254317</nct_id>
  </id_info>
  <brief_title>Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance</brief_title>
  <acronym>GSE3</acronym>
  <official_title>Dose-dependent Effect of Grape Seed Extract (GSE) on Glucose Control in People With Impaired Glucose Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Center, Illinois Institute of Technology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Nutrition Research Center, Illinois Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose&#xD;
      control in people with impaired glucose tolerance (IGT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a single-center, placebo-controlled, randomized, 4-arm, crossover study&#xD;
      that identify the lowest effective dose of GSE on glucose control in people with impaired&#xD;
      glucose tolerance.&#xD;
&#xD;
      A planned sample size of 20 will be recruited into the study. This study will require one&#xD;
      initial screening visit, pre-study visit, and 4 Oral Glucose Tolerance Test Days (OGTT) Days.&#xD;
      This study will take 4-6weeks per subject to complete.&#xD;
&#xD;
      The trial will initiate with one screening visit, which will last for about 3-4 hours where&#xD;
      the subjects' height, weight, BMI, waist circumference, fasting blood glucose, blood pressure&#xD;
      and heart rate will be measured and a survey related to general eating, health and exercise&#xD;
      habits will be completed. OGTT procedure will be performed to confirm IGT.&#xD;
&#xD;
      If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will&#xD;
      be given at the screening visit and collected on the following pre-study Visit to assess&#xD;
      subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a&#xD;
      relatively low polyphenolic-diet at least 7 days prior to the first OGTT Day and for the&#xD;
      duration of the study. A dinner meal will be provided the day before the OGTT Day to control&#xD;
      the second meal effect from food and beverage intake of the night before the OGTT Day.&#xD;
&#xD;
      Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated&#xD;
      and rested. Each OGTT Day will require blood draws throughout the visit. After evaluation of&#xD;
      subject's health status (via anthropometric, vital sign and blood glucose measurements and&#xD;
      in-person interview), a registered nurse will place a catheter in subject's arm for the&#xD;
      purpose of multiple blood sample collections and take the initial blood draw (baseline: -1h)&#xD;
      in the fasting state. 3 test capsules with 0 mg GSE, 300 mg GSE, 600 mg GSE or 900 mg GSE (in&#xD;
      forms of: 3 placebo, 2 placebo &amp; 1 GSE, 1 placebo &amp; 2 GSE or 3 GSE. Each GSE capsule&#xD;
      containing 300 mg GSE) will be served. Thereafter, timers will be started and a glucose test&#xD;
      drink (75g glucose mixed with 250ml water) will be given right after the 0h blood sampling (1&#xD;
      h after the consumption of capsules). Subject will be instructed to finish the drink in 5&#xD;
      minutes (min). From this point forward, blood sample will be collected at 30 min, 1h, 2hand&#xD;
      3h for assessment of changes in metabolic markers. The sequence of receiving the capsules&#xD;
      treatment at each visit will be randomly assigned based on computer generated sequences.&#xD;
&#xD;
      OGTT Day visits will be placed at least 3 days apart as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2014</start_date>
  <completion_date type="Actual">July 1, 2015</completion_date>
  <primary_completion_date type="Actual">June 27, 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo.</measure>
    <time_frame>4 hr</time_frame>
    <description>plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Impaired Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>0 mg placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Not containing GSE (Placebo)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>300 mg GSE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Containing 300 mg of GSE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>600 mg GSE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Containing 600 mg of GSE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>900 mg GSE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Containing 900 mg of GSE</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>0 mg placebo</intervention_name>
    <description>Not containing GSE (Placebo)</description>
    <arm_group_label>0 mg placebo</arm_group_label>
    <other_name>Placebo Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>300 mg GSE</intervention_name>
    <description>300 mg GSE</description>
    <arm_group_label>300 mg GSE</arm_group_label>
    <other_name>Active Comparator1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>600 mg GSE</intervention_name>
    <description>Containing 600 mg of GSE</description>
    <arm_group_label>600 mg GSE</arm_group_label>
    <other_name>Active Comparator2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>900 mg GSE</intervention_name>
    <description>Containing 900 mg of GSE</description>
    <arm_group_label>900 mg GSE</arm_group_label>
    <other_name>Active Comparator3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 40 to 65 years old male/female&#xD;
&#xD;
          -  Body Mass Index (BMI) less than 35kg/m2&#xD;
&#xD;
          -  Fasting blood sugar between 100-125 mg/dL&#xD;
&#xD;
          -  Confirmed impaired glucose tolerance (IGT) upon 2 hr OGTT screening test (≥ 140 mg/dL&#xD;
             &lt; 200mg/dL)&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  No clinical evidence of cardiovascular, metabolic, respiratory, renal,&#xD;
             gastrointestinal or hepatic disease&#xD;
&#xD;
          -  Not taking any medications or dietary supplements that would interfere with outcomes&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past smokers: abstinence for less than 2 years&#xD;
&#xD;
          -  Men and women who smoke&#xD;
&#xD;
          -  Men and women with known or suspected food intolerance, allergies or hypersensitivity&#xD;
             to the study materials or closely related compound or any their stated ingredients.&#xD;
&#xD;
          -  Men and women known to have/diagnosed with diabetes mellitus&#xD;
&#xD;
          -  Men and women who have fasting blood glucose concentrations ≥126 mg/dL&#xD;
&#xD;
          -  Men and women with documented vascular disease, e.g., heart failure, myocardial&#xD;
             infarction, stroke, angina, related surgeries.&#xD;
&#xD;
          -  Men and women with cancer other than non-melanoma skin cancer in previous 5 years.&#xD;
&#xD;
          -  Men and women who are taking medication or dietary supplements that may interfere with&#xD;
             the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid&#xD;
             lowering medication. Subjects may choose to go off dietary supplements (requires 30&#xD;
             days washout).&#xD;
&#xD;
          -  Men and women who have donated blood within 3 months of the screening visit and blood&#xD;
             donors/participants for whom participation in this study will result in having donated&#xD;
             more than 1500 milliliters of blood in the previous 12 months.&#xD;
&#xD;
          -  Substance (alcohol or drug) abuse within the last 2 years.&#xD;
&#xD;
          -  Excessive coffee and tea consumers (&gt; 4 cups/day)&#xD;
&#xD;
          -  Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months&#xD;
&#xD;
          -  Women who are known to be pregnant or who are intending to become pregnant over the&#xD;
             course of the study and women who are lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Britt Burton-Freeman, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Illinois Institute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eunyoung Park</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Impaired Glucose Tolerance</keyword>
  <keyword>Oral Glucose Tolerance Test</keyword>
  <keyword>Grape Seed Extract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02254317
org study id: 2014-074
nct id: NCT02254317
lead sponsor: 
has dmc: No
The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose
      control in people with impaired glucose tolerance (IGT).
The proposed study is a single-center, placebo-controlled, randomized, 4-arm, crossover study
      that identify the lowest effective dose of GSE on glucose control in people with impaired
      glucose tolerance.

      A planned sample size of 20 will be recruited into the study. This study will require one
      initial screening visit, pre-study visit, and 4 Oral Glucose Tolerance Test Days (OGTT) Days.
      This study will take 4-6weeks per subject to complete.

      The trial will initiate with one screening visit, which will last for about 3-4 hours where
      the subjects' height, weight, BMI, waist circumference, fasting blood glucose, blood pressure
      and heart rate will be measured and a survey related to general eating, health and exercise
      habits will be completed. OGTT procedure will be performed to confirm IGT.

      If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will
      be given at the screening visit and collected on the following pre-study Visit to assess
      subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a
      relatively low polyphenolic-diet at least 7 days prior to the first OGTT Day and for the
      duration of the study. A dinner meal will be provided the day before the OGTT Day to control
      the second meal effect from food and beverage intake of the night before the OGTT Day.

      Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated
      and rested. Each OGTT Day will require blood draws throughout the visit. After evaluation of
      subject's health status (via anthropometric, vital sign and blood glucose measurements and
      in-person interview), a registered nurse will place a catheter in subject's arm for the
      purpose of multiple blood sample collections and take the initial blood draw (baseline: -1h)
      in the fasting state. 3 test capsules with 0 mg GSE, 300 mg GSE, 600 mg GSE or 900 mg GSE (in
      forms of: 3 placebo, 2 placebo & 1 GSE, 1 placebo & 2 GSE or 3 GSE. Each GSE capsule
      containing 300 mg GSE) will be served. Thereafter, timers will be started and a glucose test
      drink (75g glucose mixed with 250ml water) will be given right after the 0h blood sampling (1
      h after the consumption of capsules). Subject will be instructed to finish the drink in 5
      minutes (min). From this point forward, blood sample will be collected at 30 min, 1h, 2hand
      3h for assessment of changes in metabolic markers. The sequence of receiving the capsules
      treatment at each visit will be randomly assigned based on computer generated sequences.

      OGTT Day visits will be placed at least 3 days apart as well.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo.
time frame: 4 hr
description: plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT)
arm group label: 0 mg placebo
arm group type: Placebo Comparator
description: Not containing GSE (Placebo)
arm group label: 300 mg GSE
arm group type: Active Comparator
description: Containing 300 mg of GSE
arm group label: 600 mg GSE
arm group type: Active Comparator
description: Containing 600 mg of GSE
arm group label: 900 mg GSE
arm group type: Active Comparator
description: Containing 900 mg of GSE
intervention type: Dietary Supplement
intervention name: 0 mg placebo
description: Not containing GSE (Placebo)
arm group label: 0 mg placebo
other name: Placebo Comparator
intervention type: Dietary Supplement
intervention name: 300 mg GSE
description: 300 mg GSE
arm group label: 300 mg GSE
other name: Active Comparator1
intervention type: Dietary Supplement
intervention name: 600 mg GSE
description: Containing 600 mg of GSE
arm group label: 600 mg GSE
other name: Active Comparator2
intervention type: Dietary Supplement
intervention name: 900 mg GSE
description: Containing 900 mg of GSE
arm group label: 900 mg GSE
other name: Active Comparator3
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Britt Burton-Freeman, Ph.D
role: Principal Investigator
affiliation: Illinois Institute of Technology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glucose Intolerance
sharing ipd: No