<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/NCT02197195</url>
  </required_header>
  <id_info>
    <org_study_id>REB 2013-251</org_study_id>
    <nct_id>NCT02197195</nct_id>
  </id_info>
  <brief_title>Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children</brief_title>
  <official_title>The Role of Chocolate Milk and Fruit Drink on Subjective Appetite and Glycaemic Response With or Without Exercise in Normal Weight 9-14 Year Old Boys</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toronto Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to understand the role chocolate milk compared to a fruit drink,&#xD;
      with and without exercise, on glycaemic regulation and subjective appetite in children. The&#xD;
      investigators hypothesize that chocolate milk in combination with exercise will have the&#xD;
      greatest effect attenuating glycaemic response. Blood glucose will be measured by finger&#xD;
      prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65&#xD;
      minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Glucose (mmol/L)</measure>
    <time_frame>at baseline (0), 20 and 65 minutes</time_frame>
    <description>Blood Glucose (mmol/L) determined by fingerprick glucometer reading</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Appetite (mm)</measure>
    <time_frame>0 - 65 mins</time_frame>
    <description>Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Glycemic Control</condition>
  <condition>Subjective Appetite</condition>
  <arm_group>
    <arm_group_label>Chocolate Milk Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chocolate milk beverage and sitting quietly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chocolate Milk Beverage and Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chocolate milk beverage and exercising</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fruit Drink Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fruit drink beverage and sitting quietly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fruit Drink Beverage and Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fruit drink beverage and exercising</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chocolate Milk</intervention_name>
    <arm_group_label>Chocolate Milk Beverage</arm_group_label>
    <arm_group_label>Chocolate Milk Beverage and Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fruit Drink</intervention_name>
    <arm_group_label>Fruit Drink Beverage</arm_group_label>
    <arm_group_label>Fruit Drink Beverage and Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Chocolate Milk Beverage and Exercise</arm_group_label>
    <arm_group_label>Fruit Drink Beverage and Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, boy, born at full term and normal birth weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Girls, have significant learning, behavioral, or emotional difficulties&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ryerson University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>KHS344</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 20, 2014</last_update_submitted>
  <last_update_submitted_qc>July 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Toronto Metropolitan University</investigator_affiliation>
    <investigator_full_name>Nick Bellissimo</investigator_full_name>
    <investigator_title>Assistant Professor, School of Nutrition</investigator_title>
  </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/NCT02197195
org study id: REB 2013-251
nct id: NCT02197195
lead sponsor: 
has dmc: No
The purpose of the study is to understand the role chocolate milk compared to a fruit drink,
      with and without exercise, on glycaemic regulation and subjective appetite in children. The
      investigators hypothesize that chocolate milk in combination with exercise will have the
      greatest effect attenuating glycaemic response. Blood glucose will be measured by finger
      prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65
      minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Blood Glucose (mmol/L)
time frame: at baseline (0), 20 and 65 minutes
description: Blood Glucose (mmol/L) determined by fingerprick glucometer reading
measure: Subjective Appetite (mm)
time frame: 0 - 65 mins
description: Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.
arm group label: Chocolate Milk Beverage
arm group type: Experimental
description: Chocolate milk beverage and sitting quietly
arm group label: Chocolate Milk Beverage and Exercise
arm group type: Experimental
description: Chocolate milk beverage and exercising
arm group label: Fruit Drink Beverage
arm group type: Experimental
description: Fruit drink beverage and sitting quietly
arm group label: Fruit Drink Beverage and Exercise
arm group type: Experimental
description: Fruit drink beverage and exercising
intervention type: Dietary Supplement
intervention name: Chocolate Milk
arm group label: Chocolate Milk Beverage
arm group label: Chocolate Milk Beverage and Exercise
intervention type: Dietary Supplement
intervention name: Fruit Drink
arm group label: Fruit Drink Beverage
arm group label: Fruit Drink Beverage and Exercise
intervention type: Behavioral
intervention name: Exercise
arm group label: Chocolate Milk Beverage and Exercise
arm group label: Fruit Drink Beverage and Exercise
criteria: 
gender: Male
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Toronto Metropolitan University
investigator full name: Nick Bellissimo
investigator title: Assistant Professor, School of Nutrition