<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/NCT01682174</url>
  </required_header>
  <id_info>
    <org_study_id>P12-05775</org_study_id>
    <nct_id>NCT01682174</nct_id>
  </id_info>
  <brief_title>Glycaemic Response to a Liquid Meal Tolerance Test</brief_title>
  <official_title>Effects of Dehydrated Vegetable Powder on Glycaemic Responses to a Liquid Meal Tolerance Test (LMTT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mondelēz International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Reading Scientific Services Ltd.</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>
      The purpose of this study is to assess whether added food ingredient(s) affect glycaemic&#xD;
      responses to a liquid meal tolerance test (LMTT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycaemic response (incremental area under the curve) of experimental test food using capillary blood</measure>
    <time_frame>120 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Glycaemic Index</condition>
  <condition>Glycaemic Response</condition>
  <arm_group>
    <arm_group_label>Control Test Drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>control drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Test Drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Drink</intervention_name>
    <arm_group_label>Control Test Drink</arm_group_label>
    <arm_group_label>Experimental Test Drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Drink</intervention_name>
    <arm_group_label>Control Test Drink</arm_group_label>
    <arm_group_label>Experimental Test Drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female (not less than 40% Male)&#xD;
&#xD;
          2. Aged 18 - 55 years&#xD;
&#xD;
          3. Non Smokers&#xD;
&#xD;
          4. Have a body mass index between 18.5 to 29.99 kg/m2&#xD;
&#xD;
          5. Healthy, non-diabetic, no gastric bypass surgery&#xD;
&#xD;
          6. Not allergic to dairy, or soy&#xD;
&#xD;
          7. Have a fasting plasma glucose (finger-stick) &lt;100 mg/dl (&lt;5.5 mmol/L)&#xD;
&#xD;
          8. Willing and able to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rungano Munyuki</last_name>
    <role>Principal Investigator</role>
    <affiliation>RSSL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reading Scientific Services Limited (RSSL)</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>May 7, 2013</last_update_submitted>
  <last_update_submitted_qc>May 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 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/NCT01682174
org study id: P12-05775
nct id: NCT01682174
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess whether added food ingredient(s) affect glycaemic
      responses to a liquid meal tolerance test (LMTT).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Glycaemic response (incremental area under the curve) of experimental test food using capillary blood
time frame: 120 minutes
arm group label: Control Test Drink
arm group type: Placebo Comparator
description: control drink
arm group label: Experimental Test Drink
arm group type: Experimental
description: Experimental Drink
intervention type: Other
intervention name: Control Drink
arm group label: Control Test Drink
arm group label: Experimental Test Drink
intervention type: Other
intervention name: Experimental Drink
arm group label: Control Test Drink
arm group label: Experimental Test Drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rungano Munyuki
role: Principal Investigator
affiliation: RSSL
facility: 
country: United Kingdom
responsible party type: Sponsor