<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/NCT02200796</url>
  </required_header>
  <id_info>
    <org_study_id>tempID</org_study_id>
    <nct_id>NCT02200796</nct_id>
  </id_info>
  <brief_title>Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food</brief_title>
  <official_title>Role of Dietary Protein in a Familiar Breakfast Meal on Subjective Satiety, Food Intake and Thermic Effect of Food in Normal Weight and Overweight/Obese Children</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>
      Objectives: To determine the effect of protein content of familiar breakfast meals on&#xD;
      subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in&#xD;
      normal weight (NW) and overweight (OW)/obese (OB) children.&#xD;
&#xD;
      Specific Objectives:&#xD;
&#xD;
      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying&#xD;
      in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food&#xD;
      intake at a test meal 4 h later in NW and. OW/OB children.&#xD;
&#xD;
      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in&#xD;
      protein (optimal protein from Objective 1a) or low in protein on TEF and substrate&#xD;
      utilization over 5 h in NW and OW/OB children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: The investigators hypothesize that increasing the high-quality protein content of&#xD;
      a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic&#xD;
      response, and increase the TEF in both NW and OW/OB children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">August 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>1a) Ad libitum food intake (in kcal)</measure>
    <time_frame>Four hours after breakfast</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>1b) The thermic effect of a high versus low protein meal</measure>
    <time_frame>Resting energy expenditure (REE) at baseline and up to five hours post test meal</time_frame>
    <description>REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Appetite</measure>
    <time_frame>Assessed every 15 min for 4 h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose response</measure>
    <time_frame>Measures at 15, or 60 min intervals for 4 h</time_frame>
    <description>Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Low Protein Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low Protein Test Meal (15 g)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Protein Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate Protein Meal (30 g)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Protein Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High Protein Meal (45g)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High Carbohydrate Control Meal (7 g of protein)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Meal</intervention_name>
    <description>High carbohydrate meal</description>
    <arm_group_label>Control Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Protein Meal</intervention_name>
    <description>Omelet with 15 g of protein</description>
    <arm_group_label>Low Protein Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate Protein Meal</intervention_name>
    <description>Omelet with 30 g of protein</description>
    <arm_group_label>Moderate Protein Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Protein Meal</intervention_name>
    <description>Omelet with 45 g of protein</description>
    <arm_group_label>High Protein Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Boys and girls between the ages of 9 and 14 y&#xD;
&#xD;
          -  Only peri-pubertal girls&#xD;
&#xD;
          -  Normal body weight (between the 5th and 85th BMI percentile for age and gender)&#xD;
&#xD;
          -  OW/OB (&gt;85th BMI percentile for age and gender)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food sensitivities&#xD;
&#xD;
          -  Food allergies&#xD;
&#xD;
          -  Dietary restrictions&#xD;
&#xD;
          -  Health, learning, emotional or behavioural problems&#xD;
&#xD;
          -  On any medication&#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>Ryerson University, FIRST Labaratory. 350 Victoria Street</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 2K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</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 and Director, Food Intake Regulation &amp; Satiety</investigator_title>
  </responsible_party>
  <keyword>Dietary Protein</keyword>
  <keyword>Satiety</keyword>
  <keyword>Food Intake</keyword>
  <keyword>Thermic Effect of Food</keyword>
  <keyword>Diet Induced Thermogenesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02200796
org study id: tempID
nct id: NCT02200796
lead sponsor: 
has dmc: No
Objectives: To determine the effect of protein content of familiar breakfast meals on
      subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in
      normal weight (NW) and overweight (OW)/obese (OB) children.

      Specific Objectives:

      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying
      in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food
      intake at a test meal 4 h later in NW and. OW/OB children.

      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in
      protein (optimal protein from Objective 1a) or low in protein on TEF and substrate
      utilization over 5 h in NW and OW/OB children.
Hypothesis: The investigators hypothesize that increasing the high-quality protein content of
      a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic
      response, and increase the TEF in both NW and OW/OB children.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: 1a) Ad libitum food intake (in kcal)
time frame: Four hours after breakfast
measure: 1b) The thermic effect of a high versus low protein meal
time frame: Resting energy expenditure (REE) at baseline and up to five hours post test meal
description: REE will be determined by indirect calorimetry under a ventilated hood (ParvoMedics TrueOne 2400 automated metabolic gas analysis system, Parvo Medics, USA)
measure: Subjective Appetite
time frame: Assessed every 15 min for 4 h
measure: Blood glucose response
time frame: Measures at 15, or 60 min intervals for 4 h
description: Finger prick capillary blood glucose (in mmol/L) at baseline, after breakfast (30 min), at 60 min, and in 1h intervals onward
arm group label: Low Protein Meal
arm group type: Experimental
description: Low Protein Test Meal (15 g)
arm group label: Moderate Protein Meal
arm group type: Experimental
description: Moderate Protein Meal (30 g)
arm group label: High Protein Meal
arm group type: Experimental
description: High Protein Meal (45g)
arm group label: Control Meal
arm group type: Experimental
description: High Carbohydrate Control Meal (7 g of protein)
intervention type: Other
intervention name: Control Meal
description: High carbohydrate meal
arm group label: Control Meal
intervention type: Other
intervention name: Low Protein Meal
description: Omelet with 15 g of protein
arm group label: Low Protein Meal
intervention type: Other
intervention name: Moderate Protein Meal
description: Omelet with 30 g of protein
arm group label: Moderate Protein Meal
intervention type: Other
intervention name: High Protein Meal
description: Omelet with 45 g of protein
arm group label: High Protein Meal
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: Assistant Professor and Director, Food Intake Regulation & Satiety
mesh term: Overweight