<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/NCT01717716</url>
  </required_header>
  <id_info>
    <org_study_id>REB 2010-017-001</org_study_id>
    <nct_id>NCT01717716</nct_id>
  </id_info>
  <brief_title>Sugars-containing Beverage and Food Intake in Children</brief_title>
  <official_title>Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake 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>
    <collaborator>
      <agency>Mount Saint Vincent University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Toronto Metropolitan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to determine the effect of sugars in solution on food intake and subjective&#xD;
      appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food&#xD;
      intake after all sugars-containing solutions will be decreased in comparison to the control&#xD;
      solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and&#xD;
      sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose&#xD;
      or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60&#xD;
      and 90 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>measured at 60 minutes after the treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite (mm)</measure>
    <time_frame>0-90 minutes</time_frame>
    <description>Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Calorie-free control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calorie-free control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFCS-55 drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HFCS-55 drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glucose drink</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sucrose drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>water with Sucralose</intervention_name>
    <arm_group_label>Calorie-free control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>water with HFCS</intervention_name>
    <arm_group_label>HFCS-55 drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>water with glucose</intervention_name>
    <arm_group_label>Glucose drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>water with sucrose</intervention_name>
    <arm_group_label>Sucrose drink</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;
          -  Girl, on restricted diet, taking medication that affect appetite or food intake, have&#xD;
             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>
  <overall_official>
    <last_name>Nick Bellissimo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto Metropolitan University</affiliation>
  </overall_official>
  <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 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>boys</keyword>
  <keyword>obesity</keyword>
  <keyword>glucose</keyword>
  <keyword>sucrose</keyword>
  <keyword>high-fructose corn syrup-55</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01717716
org study id: REB 2010-017-001
nct id: NCT01717716
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose is to determine the effect of sugars in solution on food intake and subjective
      appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food
      intake after all sugars-containing solutions will be decreased in comparison to the control
      solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and
      sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose
      or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60
      and 90 minutes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Food intake (kcal)
time frame: measured at 60 minutes after the treatment
measure: Subjective appetite (mm)
time frame: 0-90 minutes
description: Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.
arm group label: Calorie-free control
arm group type: Experimental
description: Calorie-free control
arm group label: HFCS-55 drink
arm group type: Experimental
description: HFCS-55 drink
arm group label: Glucose drink
arm group type: Experimental
description: Glucose drink
arm group label: Sucrose drink
arm group type: Experimental
description: Sucrose drink
intervention type: Dietary Supplement
intervention name: water with Sucralose
arm group label: Calorie-free control
intervention type: Dietary Supplement
intervention name: water with HFCS
arm group label: HFCS-55 drink
intervention type: Dietary Supplement
intervention name: water with glucose
arm group label: Glucose drink
intervention type: Dietary Supplement
intervention name: water with sucrose
arm group label: Sucrose drink
criteria: 
gender: Male
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nick Bellissimo, PhD
role: Principal Investigator
affiliation: Toronto Metropolitan University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Toronto Metropolitan University
investigator full name: Nick Bellissimo
investigator title: Assistant Professor
mesh term: Pediatric Obesity