<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/NCT01712737</url>
  </required_header>
  <id_info>
    <org_study_id>Raisins_part1_UofT</org_study_id>
    <nct_id>NCT01712737</nct_id>
  </id_info>
  <brief_title>The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children</brief_title>
  <official_title>The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Saint Vincent University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>California Raisin Marketing Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      No studies have reported the effect of pre-meal snacking on raisins compared to other&#xD;
      commonly consumed snacks on energy intake in children. Therefore, the objective of the&#xD;
      current study was to examine appetite and energy intake following consumption of ad libitum&#xD;
      snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on&#xD;
      appetite and food intake 30 min later in 8 - 11 y old normal weight children. The&#xD;
      investigators hypothesized that raisins would lower subsequent energy intake in children and&#xD;
      reduce hunger.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">May 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ad libitum snack intake (kcal)</measure>
    <time_frame>15 min</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ad libitum pizza intake (kcal)</measure>
    <time_frame>at 30 min after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective appetite</measure>
    <time_frame>0-105 min</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Food Intake Regulation</condition>
  <arm_group>
    <arm_group_label>Snack foods: raisins</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children were given ad libitum access to raisins for 15 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snack foods: grapes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children were given ad libitum access to grapes for 15 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snack foods: a mix of almonds with raisins</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children were given ad libitum access to a mix of almonds with raisins for 15 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children were given ad libitum access to water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <arm_group_label>Snack foods: a mix of almonds with raisins</arm_group_label>
    <arm_group_label>Snack foods: grapes</arm_group_label>
    <arm_group_label>Snack foods: raisins</arm_group_label>
    <arm_group_label>Water control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: healthy boys and girls between 8-11 y Exclusion criteria: learning and&#xD;
        behavioral problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvey Anderson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 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>raisins, grapes, snacks, appetite, food intake</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/NCT01712737
org study id: Raisins_part1_UofT
nct id: NCT01712737
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
No studies have reported the effect of pre-meal snacking on raisins compared to other
      commonly consumed snacks on energy intake in children. Therefore, the objective of the
      current study was to examine appetite and energy intake following consumption of ad libitum
      snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on
      appetite and food intake 30 min later in 8 - 11 y old normal weight children. The
      investigators hypothesized that raisins would lower subsequent energy intake in children and
      reduce hunger.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: ad libitum snack intake (kcal)
time frame: 15 min
measure: ad libitum pizza intake (kcal)
time frame: at 30 min after treatment
measure: subjective appetite
time frame: 0-105 min
arm group label: Snack foods: raisins
arm group type: Experimental
description: children were given ad libitum access to raisins for 15 min
arm group label: Snack foods: grapes
arm group type: Experimental
description: children were given ad libitum access to grapes for 15 min
arm group label: Snack foods: a mix of almonds with raisins
arm group type: Experimental
description: children were given ad libitum access to a mix of almonds with raisins for 15 min
arm group label: Water control
arm group type: Experimental
description: children were given ad libitum access to water
intervention type: Other
intervention name: Dietary intervention
arm group label: Snack foods: a mix of almonds with raisins
arm group label: Snack foods: grapes
arm group label: Snack foods: raisins
arm group label: Water control
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harvey Anderson, PhD
role: Principal Investigator
affiliation: University of Toronto
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: G. Harvey Anderson
investigator title: Professor