<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/NCT03248609</url>
  </required_header>
  <id_info>
    <org_study_id>1086796</org_study_id>
    <nct_id>NCT03248609</nct_id>
  </id_info>
  <brief_title>Glycemic Index of Table Grape Varietals</brief_title>
  <official_title>Investigation of the Glycemic Index of Table Grape Varietals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      Investigate the postprandial glycemic responses of healthy individuals when consuming&#xD;
      commercially available table grape varietals or grape juice, compared to a standard amount of&#xD;
      glucose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to investigate the postprandial glycemic responses of healthy individuals when&#xD;
      consuming commercially available table grape varietals, compared to a standard amount of&#xD;
      glucose. The study also aims to evaluate a new grape varietal, compared to other common table&#xD;
      grapes, with regard to glycemic index and metabolic response related to inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">June 4, 2018</completion_date>
  <primary_completion_date type="Actual">June 4, 2018</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Index</measure>
    <time_frame>3 hours</time_frame>
    <description>The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Milano grapes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unique grape varietal to test glycemic response.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Table grapes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Common grape varietal to test glycemic response and compare to the glycemic response elicited by the Milano grape varietal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grape juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Used to test the glycemic response without a complex food matrix and compare to the glycemic response elicited by the Milano grape varietal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Used to test the glycemic response with a standardized glucose beverage and compare to the glycemic response elicited by the Milano grape varietal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Milano grapes</intervention_name>
    <description>Milano grapes to test post-prandial glycemic response</description>
    <arm_group_label>Milano grapes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Table grapes</intervention_name>
    <description>Table grapes to test post-prandial glycemic response</description>
    <arm_group_label>Table grapes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Grape juice</intervention_name>
    <description>Grape juice to test post-prandial glycemic response</description>
    <arm_group_label>Grape juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucose beverage</intervention_name>
    <description>Standardized glucose beverage to test post-prandial glycemic response</description>
    <arm_group_label>Glucose beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women&#xD;
&#xD;
          -  21-75 years of age&#xD;
&#xD;
          -  BMI range 20-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adults unable to consent, individuals who are not yet adults (children), pregnant&#xD;
             women, and prisoners.&#xD;
&#xD;
          -  BMI of &gt;35 or morbid obesity.&#xD;
&#xD;
          -  Diagnosed type 1 or 2 diabetes, fasting blood glucose of &gt;125 mg/dl, or reported use&#xD;
             of medications or supplements known to affect glucose metabolism (insulin,&#xD;
             sulfonylureas, metformin, glucosidase inhibitors, thiazolidinedione, insulin&#xD;
             sensitizers, GLP-1 mimetics).&#xD;
&#xD;
          -  Medications known to affect gastrointestinal motility (prokinetic agents such as&#xD;
             reglan).&#xD;
&#xD;
          -  Renal, liver, pancreatic or cardiovascular disease, uncontrolled hypertension of &gt;&#xD;
             160/90, inflammatory bowel disease, disorders of esophageal and gastrointestinal&#xD;
             motility, previous gastric resection or restriction procedures, autoimmune or&#xD;
             immunologic disorders, anemia, breastfeeding women&#xD;
&#xD;
          -  Food allergy to grapes, or inability to tolerate gluten (celiac disease).&#xD;
&#xD;
          -  Poor venous access.&#xD;
&#xD;
          -  Smoking, illicit drug use, consuming &gt;7 alcoholic drinks per week.&#xD;
&#xD;
          -  Weight gain or loss of &gt; 5 kg within the prior 6 months.&#xD;
&#xD;
          -  Unwillingness to adhere to study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03248609
org study id: 1086796
nct id: NCT03248609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigate the postprandial glycemic responses of healthy individuals when consuming
      commercially available table grape varietals or grape juice, compared to a standard amount of
      glucose.
The study aims to investigate the postprandial glycemic responses of healthy individuals when
      consuming commercially available table grape varietals, compared to a standard amount of
      glucose. The study also aims to evaluate a new grape varietal, compared to other common table
      grapes, with regard to glycemic index and metabolic response related to inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Glycemic Index
time frame: 3 hours
description: The post-prandial glucose and insulin responses in healthy individuals to glucose containing foods or beverages.
arm group label: Milano grapes
arm group type: Experimental
description: Unique grape varietal to test glycemic response.
arm group label: Table grapes
arm group type: Active Comparator
description: Common grape varietal to test glycemic response and compare to the glycemic response elicited by the Milano grape varietal.
arm group label: Grape juice
arm group type: Active Comparator
description: Used to test the glycemic response without a complex food matrix and compare to the glycemic response elicited by the Milano grape varietal.
arm group label: Glucose beverage
arm group type: Placebo Comparator
description: Used to test the glycemic response with a standardized glucose beverage and compare to the glycemic response elicited by the Milano grape varietal.
intervention type: Other
intervention name: Milano grapes
description: Milano grapes to test post-prandial glycemic response
arm group label: Milano grapes
intervention type: Other
intervention name: Table grapes
description: Table grapes to test post-prandial glycemic response
arm group label: Table grapes
intervention type: Other
intervention name: Grape juice
description: Grape juice to test post-prandial glycemic response
arm group label: Grape juice
intervention type: Other
intervention name: Glucose beverage
description: Standardized glucose beverage to test post-prandial glycemic response
arm group label: Glucose beverage
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No