<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/NCT03015506</url>
  </required_header>
  <id_info>
    <org_study_id>01E91-16-62508</org_study_id>
    <nct_id>NCT03015506</nct_id>
  </id_info>
  <brief_title>Measuring the Glycemic Index of Pulse Based Breads</brief_title>
  <official_title>Measuring the Glycemic Index of Pulse Based Breads</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glycemic Index Laboratories, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agriculture and Agri-Food Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glycemic Index Laboratories, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the glycemic index of 4 pulse-based breads in at&#xD;
      least 10 normal healthy human volunteers. Participants will be studied in the morning on 6&#xD;
      separate days after overnight fasts. On the first and last days they will consume a test meal&#xD;
      consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they&#xD;
      will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch&#xD;
      obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over&#xD;
      2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area&#xD;
      under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after&#xD;
      white bread.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Index</measure>
    <time_frame>120 minutes</time_frame>
    <description>Glycemic index is 0.71 times F/WB where F is the incremental area under the blood glucose response curve ignoring area below fasting (AUC) elicited by a pulse bread, and WB is the mean AUC elicited by White Bread. AUC is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. The mean of the values for each pulse bread in each subject is the glycemic index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incremental area under the blood glucose response curve</measure>
    <time_frame>120 minutes</time_frame>
    <description>Incremental area under the blood glucose response curve ignoring area below fasting (AUC) is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken about 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak blood glucose concentration (Cmax)</measure>
    <time_frame>120 minutes</time_frame>
    <description>Cmax is the maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak rise of blood glucose</measure>
    <time_frame>120 minutes</time_frame>
    <description>The maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal minus the fasting blood glucose concentration.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Carbohydrate Intolerance</condition>
  <arm_group>
    <arm_group_label>White Bread</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pea Bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) pea flour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green Lentil Bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) green lentil flour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red Lentil Bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) red lentil flour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chickpea Bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) chickpea flour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bread</intervention_name>
    <arm_group_label>Chickpea Bread</arm_group_label>
    <arm_group_label>Green Lentil Bread</arm_group_label>
    <arm_group_label>Pea Bread</arm_group_label>
    <arm_group_label>Red Lentil Bread</arm_group_label>
    <arm_group_label>White Bread</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants in good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known history of HIV&#xD;
&#xD;
          -  known history of diabetes&#xD;
&#xD;
          -  history of hepatitis within the last 3 months&#xD;
&#xD;
          -  heart condition requiring hospitalization within 3 months&#xD;
&#xD;
          -  use of medications or presence of any condition which in the opinion of the study&#xD;
             physician, would increase the risk of harm to the subject or to others, or affect the&#xD;
             results of the study.&#xD;
&#xD;
          -  participants who cannot or will not comply with experimental procedures or the safety&#xD;
             guidelines of Glycemic Index Laboratories, Inc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas MS Wolever, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>April 26, 2017</last_update_submitted>
  <last_update_submitted_qc>April 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</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/NCT03015506
org study id: 01E91-16-62508
nct id: NCT03015506
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to determine the glycemic index of 4 pulse-based breads in at
      least 10 normal healthy human volunteers. Participants will be studied in the morning on 6
      separate days after overnight fasts. On the first and last days they will consume a test meal
      consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they
      will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch
      obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over
      2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area
      under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after
      white bread.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Glycemic Index
time frame: 120 minutes
description: Glycemic index is 0.71 times F/WB where F is the incremental area under the blood glucose response curve ignoring area below fasting (AUC) elicited by a pulse bread, and WB is the mean AUC elicited by White Bread. AUC is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. The mean of the values for each pulse bread in each subject is the glycemic index.
measure: Incremental area under the blood glucose response curve
time frame: 120 minutes
description: Incremental area under the blood glucose response curve ignoring area below fasting (AUC) is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken about 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat.
measure: Peak blood glucose concentration (Cmax)
time frame: 120 minutes
description: Cmax is the maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal.
measure: Peak rise of blood glucose
time frame: 120 minutes
description: The maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal minus the fasting blood glucose concentration.
arm group label: White Bread
arm group type: Active Comparator
description: Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber).
arm group label: Pea Bread
arm group type: Experimental
description: Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) pea flour.
arm group label: Green Lentil Bread
arm group type: Experimental
description: Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) green lentil flour.
arm group label: Red Lentil Bread
arm group type: Experimental
description: Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) red lentil flour.
arm group label: Chickpea Bread
arm group type: Experimental
description: Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) chickpea flour.
intervention type: Other
intervention name: Bread
arm group label: Chickpea Bread
arm group label: Green Lentil Bread
arm group label: Pea Bread
arm group label: Red Lentil Bread
arm group label: White Bread
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas MS Wolever, MD, PhD
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
responsible party type: Sponsor
sharing ipd: No