<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/NCT01725425</url>
  </required_header>
  <id_info>
    <org_study_id>8964B</org_study_id>
    <nct_id>NCT01725425</nct_id>
  </id_info>
  <brief_title>The Effect of Portion Sizes on Mood</brief_title>
  <official_title>The Impact of Portion Size of Foods on Mood in Normal Weight Adults 18-35</official_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 investigate whether different portion sizes will effect&#xD;
      overall mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this investigation is to determine whether participants will have a change&#xD;
      in mood based on the portion size of foods served. The specific aims of the study are:&#xD;
&#xD;
        1. Determine the effect of increasing portion sizes on mood.&#xD;
&#xD;
        2. Determine the effect of decreasing portion sizes on mood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total grams of snack food consumed</measure>
    <time_frame>1 year</time_frame>
    <description>The snack food consumed in this investigation is Lays Potato Chips (Frito-Lay Inc., Plano, TX). Participants will be provided 50 or 100 grams of this food at all sessions depending on which condition they are randomized into. The chips provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of chips consumed during the session will be determined by subtracting pre- and post-consumption weight of the chips.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total grams of fruit consumed</measure>
    <time_frame>1 year</time_frame>
    <description>The fruit used in this investigation is red grapes. Participants will be provided 100 grams or 150 grams of red grapes depending on which of the four groups they are participating in. Each individual will go through all four conditions in this investigation. Fruit provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of fruit consumed during the session will be determined by subtracting pre- and post-consumption weight of fruit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relative Reinforcing Value of Foods</measure>
    <time_frame>1 Year</time_frame>
    <description>As part of the investigation, participants will play a computer game which assesses the relative reinforcing value of the foods used. The number of points earned for each of the foods will be used to assess the relative reinforcing value of the foods.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Mood</condition>
  <condition>Eating Patterns</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive equal amounts of foods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increase Portion Size</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive increased portion sizes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decrease Portion Sizes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive decreased portion sizes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mixed Portion Sizes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive mixed portion sizes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The control is designed to determine average mood.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Increase Portion Size</intervention_name>
    <description>The purpose is to determine whether a change in mood will occur.</description>
    <arm_group_label>Increase Portion Size</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decrease Portion Size</intervention_name>
    <description>The purpose is to determine whether a change in mood will occur.</description>
    <arm_group_label>Decrease Portion Sizes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mixed Portions</intervention_name>
    <description>The purpose is to determine if a change in mood will occur.</description>
    <arm_group_label>Mixed Portion Sizes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-35&#xD;
&#xD;
          -  have a body mass index of 18.5 and 24.9 kg/m^2&#xD;
&#xD;
          -  be an unrestrained eater( scoring less than 12 on the Three Factor Eating&#xD;
             Questionnaire)&#xD;
&#xD;
          -  Report Being a non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently pregnant or nursing&#xD;
&#xD;
          -  report being an athlete in training&#xD;
&#xD;
          -  currently taking any medications that affect appetite or food intake&#xD;
&#xD;
          -  Have a medical condition affecting eating or are currently following a therapeutic&#xD;
             diet&#xD;
&#xD;
          -  Report disliking foods used in the investigation&#xD;
&#xD;
          -  Report having allergies to foods used in the investigation&#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>
  <overall_official>
    <last_name>Hollie Raynor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <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 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 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>
  <keyword>snack food (chips)</keyword>
  <keyword>fruit (red grapes) consumed in each condition</keyword>
  <keyword>mood</keyword>
  <!-- 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/NCT01725425
org study id: 8964B
nct id: NCT01725425
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether different portion sizes will effect
      overall mood.
The objective of this investigation is to determine whether participants will have a change
      in mood based on the portion size of foods served. The specific aims of the study are:

        1. Determine the effect of increasing portion sizes on mood.

        2. Determine the effect of decreasing portion sizes on mood.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total grams of snack food consumed
time frame: 1 year
description: The snack food consumed in this investigation is Lays Potato Chips (Frito-Lay Inc., Plano, TX). Participants will be provided 50 or 100 grams of this food at all sessions depending on which condition they are randomized into. The chips provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of chips consumed during the session will be determined by subtracting pre- and post-consumption weight of the chips.
measure: Total grams of fruit consumed
time frame: 1 year
description: The fruit used in this investigation is red grapes. Participants will be provided 100 grams or 150 grams of red grapes depending on which of the four groups they are participating in. Each individual will go through all four conditions in this investigation. Fruit provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of fruit consumed during the session will be determined by subtracting pre- and post-consumption weight of fruit.
measure: Relative Reinforcing Value of Foods
time frame: 1 Year
description: As part of the investigation, participants will play a computer game which assesses the relative reinforcing value of the foods used. The number of points earned for each of the foods will be used to assess the relative reinforcing value of the foods.
arm group label: Control
arm group type: Experimental
description: Participants will receive equal amounts of foods.
arm group label: Increase Portion Size
arm group type: Experimental
description: Participants will receive increased portion sizes.
arm group label: Decrease Portion Sizes
arm group type: Experimental
description: Participants will receive decreased portion sizes.
arm group label: Mixed Portion Sizes
arm group type: Experimental
description: Participants will receive mixed portion sizes.
intervention type: Other
intervention name: Control
description: The control is designed to determine average mood.
arm group label: Control
intervention type: Other
intervention name: Increase Portion Size
description: The purpose is to determine whether a change in mood will occur.
arm group label: Increase Portion Size
intervention type: Other
intervention name: Decrease Portion Size
description: The purpose is to determine whether a change in mood will occur.
arm group label: Decrease Portion Sizes
intervention type: Other
intervention name: Mixed Portions
description: The purpose is to determine if a change in mood will occur.
arm group label: Mixed Portion Sizes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hollie Raynor, PhD
role: Principal Investigator
affiliation: University of Tennessee
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Professor