<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/NCT02247076</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2014-038</org_study_id>
    <nct_id>NCT02247076</nct_id>
  </id_info>
  <brief_title>Does Meal Timing Affect Energy Expenditure</brief_title>
  <acronym>GRAZING</acronym>
  <official_title>Does Meal Timing Affect Energy Expenditure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Obesity Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if meal timing affects calories burned and blood&#xD;
      sugar levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      10 overweight adult men and women will eat according to two different eating schedules:&#xD;
      grazing and time-restricting feeding (&quot;early eating&quot;). While on each eating schedule,&#xD;
      metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber.&#xD;
      Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured&#xD;
      continuously. This study requires two 1-week periods of participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Energy expenditure (calories burned)</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood sugar levels</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Meal Timing</condition>
  <arm_group>
    <arm_group_label>Grazing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will eat meals spread over the course of the day (&quot;grazing&quot;).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Time-restricted feeding (early eating)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will eat meals only in the early part of the day (early lunch and very early dinner).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Grazing</intervention_name>
    <arm_group_label>Grazing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time-restricted feeding (early eating)</intervention_name>
    <arm_group_label>Time-restricted feeding (early eating)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are 20-45 years of age&#xD;
&#xD;
          -  Have a weight between 150 and 220 lbs&#xD;
&#xD;
          -  Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from&#xD;
             your height and weight)&#xD;
&#xD;
          -  If you are a female, have a regular menstrual cycle that is between 25 and 35 days&#xD;
             long&#xD;
&#xD;
          -  If you are female, had your period within the last 35 days&#xD;
&#xD;
          -  Regularly go to sleep between 9:30 pm and 12:00 am&#xD;
&#xD;
          -  Regularly eat dinner 9 or more hours after eating breakfast&#xD;
&#xD;
          -  Are willing to have about 2/3 cup of your blood stored for future research related to&#xD;
             this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have diabetes or are on anti-diabetes medication&#xD;
&#xD;
          -  Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung&#xD;
             or nervous system disease&#xD;
&#xD;
          -  Have stomach or intestinal problems&#xD;
&#xD;
          -  Regularly use medications such as steroids, beta blockers, adrenergic-stimulating&#xD;
             agents, and laxatives&#xD;
&#xD;
          -  Take any medications or supplements known to affect sleep, circadian rhythms, or&#xD;
             metabolism (with the exception that certain forms of birth control are allowed)&#xD;
&#xD;
          -  Have abnormal lab work that is clinically significant in the opinion of the study&#xD;
             physician&#xD;
&#xD;
          -  Are pregnant or lactating&#xD;
&#xD;
          -  Take the Depo Provera shot, or use an Interuterine Device (IUD) or hormone patch for&#xD;
             birth control&#xD;
&#xD;
          -  If you are on hormonal birth control, have been on a stable dose for less than 3&#xD;
             months&#xD;
&#xD;
          -  Have smoked or used nicotine/tobacco products within the last 3 months&#xD;
&#xD;
          -  Regularly do competitive sport training&#xD;
&#xD;
          -  Perform overnight shift work an average of one or more times per week&#xD;
&#xD;
          -  Have an irregular sleep schedule&#xD;
&#xD;
          -  Have an irregular eating schedule&#xD;
&#xD;
          -  Regularly drink 3 or more drinks of alcohol per day&#xD;
&#xD;
          -  Are not able or are unwilling to eat only the food and drink served to you by&#xD;
             Pennington Biomedical, while in the study&#xD;
&#xD;
          -  Are not able or are unwilling to refrain from strenuous exercise while participating&#xD;
             in the study&#xD;
&#xD;
          -  Are not able to spend 2 separate full days (for about 25 hours each) at Pennington&#xD;
             Biomedical&#xD;
&#xD;
          -  Are not able to maintain a consistent sleep schedule while participating in the study&#xD;
&#xD;
          -  Are not able to maintain a consistent eating schedule while participating in the study&#xD;
&#xD;
          -  Are not able to stop drinking coffee and other caffeine-containing drinks on the day&#xD;
             of and day prior to testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney M Peterson, PhD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Courtney Peterson</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02247076
org study id: PBRC 2014-038
nct id: NCT02247076
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to find out if meal timing affects calories burned and blood
      sugar levels.
10 overweight adult men and women will eat according to two different eating schedules:
      grazing and time-restricting feeding ("early eating"). While on each eating schedule,
      metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber.
      Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured
      continuously. This study requires two 1-week periods of participation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Energy expenditure (calories burned)
time frame: 2 days
measure: Blood sugar levels
time frame: 2 days
arm group label: Grazing
arm group type: Placebo Comparator
description: Participants will eat meals spread over the course of the day ("grazing").
arm group label: Time-restricted feeding (early eating)
arm group type: Experimental
description: Participants will eat meals only in the early part of the day (early lunch and very early dinner).
intervention type: Behavioral
intervention name: Grazing
arm group label: Grazing
intervention type: Behavioral
intervention name: Time-restricted feeding (early eating)
arm group label: Time-restricted feeding (early eating)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Courtney M Peterson, PhD, MSc
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Courtney Peterson
investigator title: Instructor