<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/NCT01664702</url>
  </required_header>
  <id_info>
    <org_study_id>HSCL15253</org_study_id>
    <secondary_id>DMI1096</secondary_id>
    <nct_id>NCT01664702</nct_id>
  </id_info>
  <brief_title>Substrate Oxidation in Children in Response to High and Low Dairy Intake</brief_title>
  <official_title>Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dairy Management Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose a randomized trial comparing higher levels of dairy intake compared&#xD;
      to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,&#xD;
      overweight (&gt;85%) who are currently consuming 1 or fewer servings of dairy per day. Each&#xD;
      participant will be randomized to either higher or lower levels of dairy intake. A baseline&#xD;
      calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet&#xD;
      they have been randomized to receive for 6 days and will then have a second calorimeter stay.&#xD;
      During this 2nd stay, each participant will continue to receive the diet they were randomized&#xD;
      to receive and will achieve a 300 kcal energy deficit through physical activity. The&#xD;
      investigators hypothesize that children who receive a 300 kcal energy deficit from the energy&#xD;
      expenditure of exercise and receive 3 to 4 servings of dairy products will show greater&#xD;
      increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of&#xD;
      exercise and receive 1 or fewer servings of dairy products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objective was to conduct a randomized clinical trial comparing enhanced levels of&#xD;
      dairy consumption to lower levels of dairy consumption during an energy deficit resulting&#xD;
      from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of&#xD;
      age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less&#xD;
      than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher&#xD;
      or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2&#xD;
      weeks of wash out. The investigators provided all meals and snacks for the participants&#xD;
      during the higher and lower dairy conditions. During the wash out period, participants were&#xD;
      instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer&#xD;
      servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at&#xD;
      baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured&#xD;
      substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2005</start_date>
  <completion_date type="Actual">December 2005</completion_date>
  <primary_completion_date type="Actual">December 2005</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>24hr fat oxidation</measure>
    <time_frame>24 hrs</time_frame>
    <description>Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24hr energy expenditure</measure>
    <time_frame>baseline, 7 days after each diet</time_frame>
    <description>Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Recommended dairy diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recommended servings of dairy products per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dairy diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One or fewer dairy servings per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dairy Products</intervention_name>
    <description>See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy</description>
    <arm_group_label>Recommended dairy diet</arm_group_label>
    <other_name>Recommended dairy servings per day</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dairy Servings</intervention_name>
    <description>Continue baseline consumption of one or fewer servings of dairy per day</description>
    <arm_group_label>Low dairy diet</arm_group_label>
    <other_name>One or fewer servings of dairy per day</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be overweight&#xD;
&#xD;
          -  and 10-13 years old&#xD;
&#xD;
          -  currently consuming 1 or fewer servings of dairy&#xD;
&#xD;
          -  less than 600 mg calcium per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not meeting the above criteria&#xD;
&#xD;
          -  must be present for duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph E Donnelly, EdD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univesity of Kansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Energy Balance Lab, The University of Kansas</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas</investigator_affiliation>
    <investigator_full_name>Joseph Donnelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dairy</keyword>
  <keyword>obesity</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/NCT01664702
org study id: HSCL15253
secondary id: DMI1096
nct id: NCT01664702
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators propose a randomized trial comparing higher levels of dairy intake compared
      to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13,
      overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each
      participant will be randomized to either higher or lower levels of dairy intake. A baseline
      calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet
      they have been randomized to receive for 6 days and will then have a second calorimeter stay.
      During this 2nd stay, each participant will continue to receive the diet they were randomized
      to receive and will achieve a 300 kcal energy deficit through physical activity. The
      investigators hypothesize that children who receive a 300 kcal energy deficit from the energy
      expenditure of exercise and receive 3 to 4 servings of dairy products will show greater
      increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of
      exercise and receive 1 or fewer servings of dairy products.
The study objective was to conduct a randomized clinical trial comparing enhanced levels of
      dairy consumption to lower levels of dairy consumption during an energy deficit resulting
      from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of
      age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less
      than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher
      or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2
      weeks of wash out. The investigators provided all meals and snacks for the participants
      during the higher and lower dairy conditions. During the wash out period, participants were
      instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer
      servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at
      baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured
      substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 24hr fat oxidation
time frame: 24 hrs
description: Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
measure: 24hr energy expenditure
time frame: baseline, 7 days after each diet
description: Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.
arm group label: Recommended dairy diet
arm group type: Experimental
description: Recommended servings of dairy products per day
arm group label: Low dairy diet
arm group type: Experimental
description: One or fewer dairy servings per day
intervention type: Dietary Supplement
intervention name: Dairy Products
description: See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
arm group label: Recommended dairy diet
other name: Recommended dairy servings per day
intervention type: Dietary Supplement
intervention name: Dairy Servings
description: Continue baseline consumption of one or fewer servings of dairy per day
arm group label: Low dairy diet
other name: One or fewer servings of dairy per day
criteria: 
gender: All
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph E Donnelly, EdD
role: Principal Investigator
affiliation: Univesity of Kansas
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas
investigator full name: Joseph Donnelly
investigator title: Professor
mesh term: Pediatric Obesity