<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/NCT01671878</url>
  </required_header>
  <id_info>
    <org_study_id>GIl1244</org_study_id>
    <nct_id>NCT01671878</nct_id>
  </id_info>
  <brief_title>Glucose and Insulin Responses to Test Foods</brief_title>
  <official_title>Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mondelēz International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glycemic Index Laboratories, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mondelēz International, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, postprandial glucose and insulin responses of different foods will be measured&#xD;
      in individuals with varying body weight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial Glucose Response</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial Insulin Response</measure>
    <time_frame>3 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Glucose Response</condition>
  <condition>Insulin Response</condition>
  <arm_group>
    <arm_group_label>Reference Glucose</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Glucose standard</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Food 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cereal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Food 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biscuit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reference Glucose</intervention_name>
    <arm_group_label>Reference Glucose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test Food 1 (Cereal)</intervention_name>
    <arm_group_label>Test Food 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test Food 2 (Biscuit)</intervention_name>
    <arm_group_label>Test Food 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be non-smoking males or non-pregnant females aged 20-45y, with&#xD;
             normal glycemia and in good health. A total of 12 participants will be included, where&#xD;
             approximately half will be male &amp; half female, and half normal weight (BMI &gt; 19.0 and&#xD;
             &lt; 25.0) and half overweight but not obese (BMI &gt; 25.0 and &lt; 30). Thus, no fewer than 5&#xD;
             male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be&#xD;
             included. Additional inclusion criteria will include:&#xD;
&#xD;
          -  Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined&#xD;
             as having a fasting plasma glucose &lt; 5.6 mmol/L (100 mg/dL) AND plasma glucose levels&#xD;
             &lt; 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be&#xD;
             administered during the screening visit)&#xD;
&#xD;
          -  Systolic blood pressure 100-150 mmHg inclusive&#xD;
&#xD;
          -  Diastolic blood pressure 60-90 mmHg inclusive&#xD;
&#xD;
          -  Resting heart rate 50-90 beats/min inclusive after 3 minute rest&#xD;
&#xD;
          -  Able to refrain from eating legumes and drinking alcohol the day before each test&#xD;
             session&#xD;
&#xD;
          -  Fasting triglycerides &lt; 2.0 mmol/L (178 mg/dL)&#xD;
&#xD;
          -  Fasting HDL cholesterol &gt; 0.9 mmol/L (35 mg/dL) for males and &gt; 1.1mmol/L (42 mg/dL)&#xD;
             for females&#xD;
&#xD;
          -  Fasting LDL cholesterol &lt; 5.0 mmol/L (193 mg/dL)&#xD;
&#xD;
          -  AST and ALT &lt; 120% of upper limit of normal (ULN)&#xD;
&#xD;
          -  hsCRP &lt; 10 mg/L&#xD;
&#xD;
          -  Urea and creatinine &lt; 150% ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  failure to meet any one of the inclusion criteria&#xD;
&#xD;
          -  age less than 18 or over 45 years&#xD;
&#xD;
          -  known history or AIDS, hepatitis, diabetes or a heart condition&#xD;
&#xD;
          -  participants using medications or with any condition which might, in the opinion of&#xD;
             Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to&#xD;
             the subject or to others, or 2) affect the results&#xD;
&#xD;
          -  participants who cannot or will not comply with the experimental procedures or do not&#xD;
             follow GI Labs safety guidelines.&#xD;
&#xD;
          -  Food allergies of any kind&#xD;
&#xD;
          -  General anaesthesia in the month prior to inclusion.&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Wolever, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glycemic Index Laboratories</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>May 6, 2013</last_update_submitted>
  <last_update_submitted_qc>May 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01671878
org study id: GIl1244
nct id: NCT01671878
lead sponsor: 
collaborator: 
has dmc: No
In this study, postprandial glucose and insulin responses of different foods will be measured
      in individuals with varying body weight.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Postprandial Glucose Response
time frame: 3 hours
measure: Postprandial Insulin Response
time frame: 3 hours
arm group label: Reference Glucose
arm group type: Other
description: Glucose standard
arm group label: Test Food 1
arm group type: Experimental
description: Cereal
arm group label: Test Food 2
arm group type: Experimental
description: Biscuit
intervention type: Other
intervention name: Reference Glucose
arm group label: Reference Glucose
intervention type: Other
intervention name: Test Food 1 (Cereal)
arm group label: Test Food 1
intervention type: Other
intervention name: Test Food 2 (Biscuit)
arm group label: Test Food 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Wolever, MD, PhD
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
facility: 
country: Canada
responsible party type: Sponsor