<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/NCT01720589</url>
  </required_header>
  <id_info>
    <org_study_id>2012-33610-19482</org_study_id>
    <nct_id>NCT01720589</nct_id>
  </id_info>
  <brief_title>Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children</brief_title>
  <acronym>Melt</acronym>
  <official_title>Development of Rich &amp; Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's-Roosevelt Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prosperity Organic Foods</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's-Roosevelt Hospital Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich&#xD;
      in medium chain triglycerides on energy expenditure and food intake in overweight and obese&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thermic effect of food</measure>
    <time_frame>6 h</time_frame>
    <description>Measurement of thermic effect of food over 6 hours after a meal rich in test oil and control oil. The thermic effect of food is the difference between post-prandial energy expenditure and basal energy expenditure. We will assess the difference in thermic effect of food over a 6-hour period between the test oil and the control oil.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory quotient/fat oxidation</measure>
    <time_frame>6 h</time_frame>
    <description>Measurement of substrate oxidation by indirect calorimetry over 6 hours after consumption of the test oil and control oil. We will specifically calculate carbohydrate and fat oxidation rates over the 6-hour period post-prandially and compare rates of oxidation of these two substrates between the test oil and the control oil.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food intake</measure>
    <time_frame>single meal</time_frame>
    <description>Measurement of food intake at a single meal served 1 hour after a pre-load containing 8-10 g of the test oil and the control oil</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>6 h</time_frame>
    <description>Measurement of glucose over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feelings of appetite and satiety</measure>
    <time_frame>6 h</time_frame>
    <description>Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>6 hours</time_frame>
    <description>Measurement of insulin over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leptin</measure>
    <time_frame>6 hours</time_frame>
    <description>Measurement of leptin over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ghrelin</measure>
    <time_frame>6 hours</time_frame>
    <description>Measurement of ghrelin over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peptide YY</measure>
    <time_frame>6 hours</time_frame>
    <description>Measurement of peptide YY over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucagon like peptide 1</measure>
    <time_frame>6 hours</time_frame>
    <description>Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Melt (test oil)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume a muffin containing 20 g of dietary fat provided by the test oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the test oil and their food intake at an ad libitum meal will be measured 1 hour later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corn oil (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume a muffin containing 20 g of dietary fat provided by the control oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the control oil and their food intake at an ad libitum meal will be measured 1 hour later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Melt (test oil)</intervention_name>
    <arm_group_label>Melt (test oil)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Corn oil (control)</intervention_name>
    <arm_group_label>Corn oil (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 15-18&#xD;
&#xD;
          -  body mass index 85% percentile or higher for age/sex&#xD;
&#xD;
          -  weight stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ±5 lbs weight change in the the 3 months prior&#xD;
&#xD;
          -  use of medications&#xD;
&#xD;
          -  dietary allergies&#xD;
&#xD;
          -  metabolic disorder&#xD;
&#xD;
          -  eating disorder&#xD;
&#xD;
          -  behavioral or psychological disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Pierre St-Onge, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Luke's-Roosevelt Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cygnia Rapp</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prosperity Organic Foods</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Luke's/Roosevelt Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>May 28, 2013</last_update_submitted>
  <last_update_submitted_qc>May 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Luke's-Roosevelt Hospital Center</investigator_affiliation>
    <investigator_full_name>Marie-Pierre St-Onge</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Dietary fat</keyword>
  <keyword>Energy expenditure</keyword>
  <keyword>Food intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <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/NCT01720589
org study id: 2012-33610-19482
nct id: NCT01720589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich
      in medium chain triglycerides on energy expenditure and food intake in overweight and obese
      children.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Thermic effect of food
time frame: 6 h
description: Measurement of thermic effect of food over 6 hours after a meal rich in test oil and control oil. The thermic effect of food is the difference between post-prandial energy expenditure and basal energy expenditure. We will assess the difference in thermic effect of food over a 6-hour period between the test oil and the control oil.
measure: Respiratory quotient/fat oxidation
time frame: 6 h
description: Measurement of substrate oxidation by indirect calorimetry over 6 hours after consumption of the test oil and control oil. We will specifically calculate carbohydrate and fat oxidation rates over the 6-hour period post-prandially and compare rates of oxidation of these two substrates between the test oil and the control oil.
measure: Food intake
time frame: single meal
description: Measurement of food intake at a single meal served 1 hour after a pre-load containing 8-10 g of the test oil and the control oil
measure: Glucose
time frame: 6 h
description: Measurement of glucose over 6 hours after consumption of the test oil and control oil
measure: Feelings of appetite and satiety
time frame: 6 h
description: Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil
measure: Insulin
time frame: 6 hours
description: Measurement of insulin over 6 hours after consumption of the test oil and control oil
measure: Leptin
time frame: 6 hours
description: Measurement of leptin over 6 hours after consumption of the test oil and control oil
measure: Ghrelin
time frame: 6 hours
description: Measurement of ghrelin over 6 hours after consumption of the test oil and control oil
measure: Peptide YY
time frame: 6 hours
description: Measurement of peptide YY over 6 hours after consumption of the test oil and control oil
measure: Glucagon like peptide 1
time frame: 6 hours
description: Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil
arm group label: Melt (test oil)
arm group type: Experimental
description: Participants will consume a muffin containing 20 g of dietary fat provided by the test oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the test oil and their food intake at an ad libitum meal will be measured 1 hour later.
arm group label: Corn oil (control)
arm group type: Active Comparator
description: Participants will consume a muffin containing 20 g of dietary fat provided by the control oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the control oil and their food intake at an ad libitum meal will be measured 1 hour later.
intervention type: Dietary Supplement
intervention name: Melt (test oil)
arm group label: Melt (test oil)
intervention type: Dietary Supplement
intervention name: Corn oil (control)
arm group label: Corn oil (control)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie-Pierre St-Onge, Ph.D
role: Principal Investigator
affiliation: St. Luke's-Roosevelt Hospital Center
last name: Cygnia Rapp
role: Principal Investigator
affiliation: Prosperity Organic Foods
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Luke's-Roosevelt Hospital Center
investigator full name: Marie-Pierre St-Onge
investigator title: Research Associate
mesh term: Obesity
mesh term: Pediatric Obesity