<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/NCT01734590</url>
  </required_header>
  <id_info>
    <org_study_id>FDS-NAA-0758</org_study_id>
    <nct_id>NCT01734590</nct_id>
  </id_info>
  <brief_title>Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood</brief_title>
  <official_title>The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unilever R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.&#xD;
&#xD;
      The main objective is to identify one or two flour compositions in a carbohydrate-based food&#xD;
      that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative&#xD;
      absorption of exogenous glucose compared to the control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve volunteers will participate in the study; each person will be studied on three&#xD;
      different occasions at least one week apart, consuming the three different test products in a&#xD;
      randomized order. Test products are carbohydrate-based food made from different flour mixes&#xD;
      differing in their expected rate of intestinal starch digestion. The products are labeled&#xD;
      with 13C starch.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.</measure>
    <time_frame>Measured during 360 min for 3 periods</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total blood glucose and insulin</measure>
    <time_frame>Measured during 360 min for 3 periods</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Carbohydrate based food mix 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Slowly digestible carbohydrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate based food mix 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Slowly digestible carbohydrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control carbohydrate based food</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapidly digestible carbohydrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrate based food mix 1</intervention_name>
    <description>Carbohydrate based food</description>
    <arm_group_label>Carbohydrate based food mix 2</arm_group_label>
    <arm_group_label>Control carbohydrate based food</arm_group_label>
    <other_name>Slowly digestible carbohydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrate based food mix 2</intervention_name>
    <description>Carbohydrate based food</description>
    <arm_group_label>Carbohydrate based food mix 1</arm_group_label>
    <arm_group_label>Control carbohydrate based food</arm_group_label>
    <other_name>Slowly digestible carbohydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control carbohydrate based food</intervention_name>
    <description>Carbohydrate based food</description>
    <arm_group_label>Carbohydrate based food mix 1</arm_group_label>
    <arm_group_label>Carbohydrate based food mix 2</arm_group_label>
    <other_name>Rapidly digestible carbohydrate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  healthy males&#xD;
&#xD;
          -  Age at start of the study ≥18 and ≤ 50 years&#xD;
&#xD;
          -  Not smoking&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2&#xD;
&#xD;
          -  Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110&#xD;
             mg/dl) at screening&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khalid Abd-Elaziz</last_name>
    <role>Principal Investigator</role>
    <affiliation>QPS Netherlands BV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QPS</name>
      <address>
        <city>Groningen</city>
        <state>Hanzeplein 1</state>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>June 18, 2013</last_update_submitted>
  <last_update_submitted_qc>June 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Flour,</keyword>
  <keyword>carbohydrate,</keyword>
  <keyword>digestibility</keyword>
  <keyword>subjects</keyword>
  <!-- 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/NCT01734590
org study id: FDS-NAA-0758
nct id: NCT01734590
lead sponsor: 
has dmc: No
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.

      The main objective is to identify one or two flour compositions in a carbohydrate-based food
      that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative
      absorption of exogenous glucose compared to the control.
Twelve volunteers will participate in the study; each person will be studied on three
      different occasions at least one week apart, consuming the three different test products in a
      randomized order. Test products are carbohydrate-based food made from different flour mixes
      differing in their expected rate of intestinal starch digestion. The products are labeled
      with 13C starch.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
time frame: Measured during 360 min for 3 periods
measure: Total blood glucose and insulin
time frame: Measured during 360 min for 3 periods
arm group label: Carbohydrate based food mix 1
arm group type: Experimental
description: Slowly digestible carbohydrate
arm group label: Carbohydrate based food mix 2
arm group type: Experimental
description: Slowly digestible carbohydrate
arm group label: Control carbohydrate based food
arm group type: Active Comparator
description: Rapidly digestible carbohydrate
intervention type: Dietary Supplement
intervention name: Carbohydrate based food mix 1
description: Carbohydrate based food
arm group label: Carbohydrate based food mix 2
arm group label: Control carbohydrate based food
other name: Slowly digestible carbohydrate
intervention type: Dietary Supplement
intervention name: Carbohydrate based food mix 2
description: Carbohydrate based food
arm group label: Carbohydrate based food mix 1
arm group label: Control carbohydrate based food
other name: Slowly digestible carbohydrate
intervention type: Dietary Supplement
intervention name: Control carbohydrate based food
description: Carbohydrate based food
arm group label: Carbohydrate based food mix 1
arm group label: Carbohydrate based food mix 2
other name: Rapidly digestible carbohydrate
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khalid Abd-Elaziz
role: Principal Investigator
affiliation: QPS Netherlands BV
facility: 
country: Netherlands
responsible party type: Sponsor