<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/NCT01717703</url>
  </required_header>
  <id_info>
    <org_study_id>REB 2009-020-001</org_study_id>
    <nct_id>NCT01717703</nct_id>
  </id_info>
  <brief_title>Sugars-sweetened Commercial Beverages on Short-term Food Intake</brief_title>
  <official_title>Effect of Sugars-Sweetened Commercial Beverages on Short-Term Food Intake Regulation in Normal Weight and Overweight/Obese 9-14 Year Old Boys and Girls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Saint Vincent University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Toronto Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate&#xD;
      milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when&#xD;
      compared to cola, a fruit drink and a water control in normal weight and overweight/obese&#xD;
      9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal&#xD;
      time satiation to a greater extent than other sugars-sweetened commercially available&#xD;
      beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water,&#xD;
      fruit drink, cola or 1% chocolate milk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food intake (kcal)</measure>
    <time_frame>60 min after the treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite (in mm)</measure>
    <time_frame>0-90 min</time_frame>
    <description>Subjective appetite by visual analogue scale (mm) measured at 0, 15, 30, 45, 60 and 90 minutes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Water Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Water Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fruit drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fruit drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cola</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cola</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1% chocolate milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1% chocolate milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Water</intervention_name>
    <arm_group_label>Water Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fruit drink</intervention_name>
    <arm_group_label>Fruit drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cola</intervention_name>
    <arm_group_label>Cola</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>1% chocolate milk</intervention_name>
    <arm_group_label>1% chocolate milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy boys and girls 9-14 years of age, stable weight, born at full term, normal&#xD;
             birth weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  restricted diet, taking medications that affect food intake, significant learning,&#xD;
             behavioral or emotional problems, food allergies to test treatments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Applied Human Nutrition</name>
      <address>
        <city>Bedford</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</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>Assisstant Professor</investigator_title>
  </responsible_party>
  <keyword>prevention</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/NCT01717703
org study id: REB 2009-020-001
nct id: NCT01717703
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate
      milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when
      compared to cola, a fruit drink and a water control in normal weight and overweight/obese
      9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal
      time satiation to a greater extent than other sugars-sweetened commercially available
      beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water,
      fruit drink, cola or 1% chocolate milk.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Food intake (kcal)
time frame: 60 min after the treatment
measure: Subjective appetite (in mm)
time frame: 0-90 min
description: Subjective appetite by visual analogue scale (mm) measured at 0, 15, 30, 45, 60 and 90 minutes.
arm group label: Water Control
arm group type: Experimental
description: Water Control
arm group label: Fruit drink
arm group type: Experimental
description: Fruit drink
arm group label: Cola
arm group type: Experimental
description: Cola
arm group label: 1% chocolate milk
arm group type: Experimental
description: 1% chocolate milk
intervention type: Dietary Supplement
intervention name: Water
arm group label: Water Control
intervention type: Dietary Supplement
intervention name: Fruit drink
arm group label: Fruit drink
intervention type: Dietary Supplement
intervention name: Cola
arm group label: Cola
intervention type: Dietary Supplement
intervention name: 1% chocolate milk
arm group label: 1% chocolate milk
criteria: 
gender: All
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: Assisstant Professor