<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/NCT02211599</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC507</org_study_id>
    <nct_id>NCT02211599</nct_id>
  </id_info>
  <brief_title>Fat Burning After a Meal</brief_title>
  <official_title>Post-Prandial Substrate Utilization in Response to the Inclusion of Sweetened Beverage to Meals With Different Levels of Protein Content</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Grand Forks Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Grand Forks Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine how adding a carbohydrate beverage to a meal with&#xD;
      different protein levels affects the rate at which one's body burns fats, sugars, and&#xD;
      proteins.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial lipid oxidation rate</measure>
    <time_frame>4 hours after meal consumption</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy expenditure measured by postprandial thermogenesis</measure>
    <time_frame>4 hours after meal consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial protein oxidation</measure>
    <time_frame>4 hours after meal consumption</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial carbohydrate oxidation</measure>
    <time_frame>4 hours after meal consumption</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Postprandial Effect of Carbohydrate Beverage Consumption</condition>
  <arm_group>
    <arm_group_label>15% protein meal and sweetened beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breakfast and lunch will each contain 15% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30% protein meal and sweetened beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breakfast and lunch will each contain 30% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>15% protein</intervention_name>
    <description>Meal to provide 15%en from protein.</description>
    <arm_group_label>15% protein meal and sweetened beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>30% protein</intervention_name>
    <description>Meal to provide 30%en from protein.</description>
    <arm_group_label>30% protein meal and sweetened beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sweetened beverage</intervention_name>
    <description>Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).</description>
    <arm_group_label>15% protein meal and sweetened beverage</arm_group_label>
    <arm_group_label>30% protein meal and sweetened beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI less than 25 kg/m2&#xD;
&#xD;
          -  ability to sign the consent form&#xD;
&#xD;
          -  availability of transportation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  percent body fat greater than or equal to 25% for males and 35% for females&#xD;
&#xD;
          -  allergies to any study foods&#xD;
&#xD;
          -  more than a 10% change in body weight within the past 2 months&#xD;
&#xD;
          -  current or planned pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  metabolic illness/disease(s)&#xD;
&#xD;
          -  active cancer or in short-term remission (less than 3 years)&#xD;
&#xD;
          -  infectious diseases&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  tobacco use&#xD;
&#xD;
          -  presence of acute illness&#xD;
&#xD;
          -  taking medications known to affect energy expenditure and appetite&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shanon Casperson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA Grand Forks Human Nutrition Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Roemmich, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA Grand Forks Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA Grand Forks Human Nutrition Research Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>protein</keyword>
  <keyword>carbohydrate</keyword>
  <keyword>lipid</keyword>
  <keyword>oxidation</keyword>
  <keyword>fat</keyword>
  <keyword>sugar</keyword>
  <keyword>juice</keyword>
  <keyword>obesity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02211599
org study id: GFHNRC507
nct id: NCT02211599
lead sponsor: 
has dmc: No
The purpose of the study is to determine how adding a carbohydrate beverage to a meal with
      different protein levels affects the rate at which one's body burns fats, sugars, and
      proteins.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Postprandial lipid oxidation rate
time frame: 4 hours after meal consumption
measure: Energy expenditure measured by postprandial thermogenesis
time frame: 4 hours after meal consumption
measure: Postprandial protein oxidation
time frame: 4 hours after meal consumption
measure: Postprandial carbohydrate oxidation
time frame: 4 hours after meal consumption
arm group label: 15% protein meal and sweetened beverage
arm group type: Experimental
description: Breakfast and lunch will each contain 15% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.
arm group label: 30% protein meal and sweetened beverage
arm group type: Experimental
description: Breakfast and lunch will each contain 30% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.
intervention type: Other
intervention name: 15% protein
description: Meal to provide 15%en from protein.
arm group label: 15% protein meal and sweetened beverage
intervention type: Other
intervention name: 30% protein
description: Meal to provide 30%en from protein.
arm group label: 30% protein meal and sweetened beverage
intervention type: Other
intervention name: Sweetened beverage
description: Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).
arm group label: 15% protein meal and sweetened beverage
arm group label: 30% protein meal and sweetened beverage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shanon Casperson, PhD
role: Principal Investigator
affiliation: USDA Grand Forks Human Nutrition Research Center
last name: James Roemmich, PhD
role: Principal Investigator
affiliation: USDA Grand Forks Human Nutrition Research Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No