<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/NCT01731522</url>
  </required_header>
  <id_info>
    <org_study_id>MTRI-Basic EF Study</org_study_id>
    <nct_id>NCT01731522</nct_id>
  </id_info>
  <brief_title>Eating Frequency Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the influence of two Eating Frequency prescriptions,&#xD;
      meal (energy intake occurring during three meals per day) and grazing (energy intake&#xD;
      occurring every two to three hours per day), on consumption during an ad libitum meal&#xD;
      consumed at the end of the day, overall daily energy intake, and ratio of energy intake to&#xD;
      energy expenditure. It is hypothesized that the grazing condition will produce lower&#xD;
      consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio&#xD;
      of energy intake to energy expenditure than the meal condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 men and women of healthy weight will participate in this study. The complete study design&#xD;
      will be a 2 x 2 mixed factorial design, with the between-subject factor of order and a&#xD;
      within-subject factor of eating condition (meal or grazing). Depending upon the eating&#xD;
      condition, participants will be provided with a morning meal and an afternoon meal (meal) or&#xD;
      two small meals and three snacks to be consumed every 2-3 hours (grazing). The types of foods&#xD;
      and amount of foods provided to participants will be identical in each condition; the only&#xD;
      difference in the conditions is the time spacing during the day when the foods are consumed.&#xD;
      The primary dependent variable will be amount, both grams and energy, of food consumed during&#xD;
      an ad libitum meal consumed in the evening at the completion of the meal condition, overall&#xD;
      daily energy intake, and ratio of daily energy intake to energy expenditure. It is&#xD;
      hypothesized that the grazing condition will produce lower consumption during an evening ad&#xD;
      libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy&#xD;
      expenditure than the meal condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total grams of ad libitum meal consumed</measure>
    <time_frame>1 year</time_frame>
    <description>The foods that will be used in this investigation are Tyson Chicken Breast Tenders, Ore-Ida Tater Tots, Birds Eye Steamfresh Pure &amp; Simple green beans, and Sarah Lee Butter Pound Cake. Participants will be provided with ad libitum amounts of the foods, and the foods will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the meal. The weight of the container will also be measured. Total grams of each food consumed during the session will be determined by subtracting pre- and post-consumption weight of food.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Eating Frequency</condition>
  <arm_group>
    <arm_group_label>EF condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EF condition</intervention_name>
    <arm_group_label>EF condition</arm_group_label>
    <other_name>Grazing, Three meal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 35 years&#xD;
&#xD;
          -  body mass index (BMI) between 18.5 and 24.9 kg/m2&#xD;
&#xD;
          -  no history of overweight or obesity&#xD;
&#xD;
          -  unrestrained eater (&lt;12 on Three Factor Eating Questionnaire [TFEQ])&#xD;
&#xD;
          -  regularly participate in at least 150 minutes of moderate-intense physical activity&#xD;
             per week over the previous 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently taking medication that affects appetite or food intake&#xD;
&#xD;
          -  have a medical condition affecting eating or currently following a therapeutic diet&#xD;
&#xD;
          -  are currently participating in a weight loss program and/or taking weight loss&#xD;
             medication&#xD;
&#xD;
          -  have gained or lost &gt; 5% of body weight during the past 6 months&#xD;
&#xD;
          -  diagnosed with type 1 or 2 diabetes&#xD;
&#xD;
          -  have had bariatric surgery&#xD;
&#xD;
          -  report disliking foods used in the investigation (scoring a 1 or 2 on a 5-point Likert&#xD;
             scale)&#xD;
&#xD;
          -  report having allergies to foods used in the investigation&#xD;
&#xD;
          -  currently smoke&#xD;
&#xD;
          -  report binge eating&#xD;
&#xD;
          -  are graduate students in the Department of Nutrition&#xD;
&#xD;
          -  are pregnant, lactating, &lt; 6 months post-partum.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Tennessee-Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996-1920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Professor</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/NCT01731522
org study id: MTRI-Basic EF Study
nct id: NCT01731522
lead sponsor: 
has dmc: No
The purpose of this study is to examine the influence of two Eating Frequency prescriptions,
      meal (energy intake occurring during three meals per day) and grazing (energy intake
      occurring every two to three hours per day), on consumption during an ad libitum meal
      consumed at the end of the day, overall daily energy intake, and ratio of energy intake to
      energy expenditure. It is hypothesized that the grazing condition will produce lower
      consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio
      of energy intake to energy expenditure than the meal condition.
20 men and women of healthy weight will participate in this study. The complete study design
      will be a 2 x 2 mixed factorial design, with the between-subject factor of order and a
      within-subject factor of eating condition (meal or grazing). Depending upon the eating
      condition, participants will be provided with a morning meal and an afternoon meal (meal) or
      two small meals and three snacks to be consumed every 2-3 hours (grazing). The types of foods
      and amount of foods provided to participants will be identical in each condition; the only
      difference in the conditions is the time spacing during the day when the foods are consumed.
      The primary dependent variable will be amount, both grams and energy, of food consumed during
      an ad libitum meal consumed in the evening at the completion of the meal condition, overall
      daily energy intake, and ratio of daily energy intake to energy expenditure. It is
      hypothesized that the grazing condition will produce lower consumption during an evening ad
      libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy
      expenditure than the meal condition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Total grams of ad libitum meal consumed
time frame: 1 year
description: The foods that will be used in this investigation are Tyson Chicken Breast Tenders, Ore-Ida Tater Tots, Birds Eye Steamfresh Pure & Simple green beans, and Sarah Lee Butter Pound Cake. Participants will be provided with ad libitum amounts of the foods, and the foods will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the meal. The weight of the container will also be measured. Total grams of each food consumed during the session will be determined by subtracting pre- and post-consumption weight of food.
arm group label: EF condition
arm group type: Experimental
intervention type: Behavioral
intervention name: EF condition
arm group label: EF condition
other name: Grazing, Three meal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Professor