<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/NCT01673321</url>
  </required_header>
  <id_info>
    <org_study_id>27226</org_study_id>
    <nct_id>NCT01673321</nct_id>
  </id_info>
  <brief_title>Protein Concentrations in Yogurt and Satiety, Food Intake and Glycemia in Healthy Men</brief_title>
  <official_title>Effect of Varied Protein Concentrations in Greek Yogurt on Glycemic Response, Satiety and Next Meal Food Intake in Healthy Young Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Natural Sciences and Engineering Research Council, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dairy Farmers of Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mondelēz International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compared the effects of dairy products, including milk and yogurt, with different&#xD;
      amounts of proteins on responses of appetite, glucose and insulin and on food intake at a&#xD;
      meal served 120 minutes later in healthy adult male individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food intake</measure>
    <time_frame>120 minutes after consumption of treatments</time_frame>
    <description>Calories consumed at the test meal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemia</measure>
    <time_frame>Pre-(0-120 min) and post-(120-260 min) meal periods</time_frame>
    <description>Glycemic responses in the pre- and post-test meal periods</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Appetite</measure>
    <time_frame>Pre-(0-120 min) and post-(120-260 min) meal periods</time_frame>
    <description>Appetite scores in the pre- and post-test meal periods</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <condition>Glucose Metabolism</condition>
  <arm_group>
    <arm_group_label>Non-fat Yogurt-Plain flavored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein to carbohydrate ratio: 2.30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skim milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein to carbohydrate ratio: 0.69</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-fat Yogurt with honey-Plain flavored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein to carbohydrate ratio: 1.24</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein to carbohydrate ratio: 0.07</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-fat Yogurt-Strawberry flavored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein to carbohydrate ratio: 0.79</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>All snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast.</description>
    <arm_group_label>Non-fat Yogurt with honey-Plain flavored</arm_group_label>
    <arm_group_label>Non-fat Yogurt-Plain flavored</arm_group_label>
    <arm_group_label>Non-fat Yogurt-Strawberry flavored</arm_group_label>
    <arm_group_label>Orange juice</arm_group_label>
    <arm_group_label>Skim milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20-30 years&#xD;
&#xD;
          -  Body mass index: 20 and 24.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breakfast skippers,&#xD;
&#xD;
          -  Smokers,&#xD;
&#xD;
          -  Dieters,&#xD;
&#xD;
          -  Individuals with lactose-intolerance or who are allergic to milk,&#xD;
&#xD;
          -  Individuals with gastrointestinal problems and&#xD;
&#xD;
          -  Individuals with diabetes or other metabolic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>G. Harvey Anderson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutritional Sciences, University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 3E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>G. Harvey Anderson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Yogurt</keyword>
  <keyword>Milk</keyword>
  <keyword>Protein</keyword>
  <keyword>Food intake</keyword>
  <keyword>Appetite</keyword>
  <keyword>Glucose</keyword>
  <keyword>Insulin</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/NCT01673321
org study id: 27226
nct id: NCT01673321
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study compared the effects of dairy products, including milk and yogurt, with different
      amounts of proteins on responses of appetite, glucose and insulin and on food intake at a
      meal served 120 minutes later in healthy adult male individuals.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Food intake
time frame: 120 minutes after consumption of treatments
description: Calories consumed at the test meal
measure: Glycemia
time frame: Pre-(0-120 min) and post-(120-260 min) meal periods
description: Glycemic responses in the pre- and post-test meal periods
measure: Appetite
time frame: Pre-(0-120 min) and post-(120-260 min) meal periods
description: Appetite scores in the pre- and post-test meal periods
arm group label: Non-fat Yogurt-Plain flavored
arm group type: Experimental
description: Protein to carbohydrate ratio: 2.30
arm group label: Skim milk
arm group type: Experimental
description: Protein to carbohydrate ratio: 0.69
arm group label: Non-fat Yogurt with honey-Plain flavored
arm group type: Experimental
description: Protein to carbohydrate ratio: 1.24
arm group label: Orange juice
arm group type: Experimental
description: Protein to carbohydrate ratio: 0.07
arm group label: Non-fat Yogurt-Strawberry flavored
arm group type: Experimental
description: Protein to carbohydrate ratio: 0.79
intervention type: Other
intervention name: Dietary intervention
description: All snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast.
arm group label: Non-fat Yogurt with honey-Plain flavored
arm group label: Non-fat Yogurt-Plain flavored
arm group label: Non-fat Yogurt-Strawberry flavored
arm group label: Orange juice
arm group label: Skim milk
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: G. Harvey Anderson, Professor
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: G. Harvey Anderson
investigator title: Professor