<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/NCT01729390</url>
  </required_header>
  <id_info>
    <org_study_id>FoodED501</org_study_id>
    <secondary_id>5R01DK059853-11</secondary_id>
    <nct_id>NCT01729390</nct_id>
  </id_info>
  <brief_title>Varying the Energy Density and Portion Size of the Main Course After a First-course Salad</brief_title>
  <official_title>Varying the Energy Density and Portion Size of the Main Course After a First-course Salad</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to determine whether varying the energy density and portion&#xD;
      size of the main course will affect meal energy intake after consumption of a first course&#xD;
      that has previously been shown to enhance satiety. It is hypothesized that increasing either&#xD;
      the energy density or portion size of the main course will increase meal energy intake after&#xD;
      consumption of the first course. It is also hypothesized that compared to when a first course&#xD;
      is consumed, not consuming a first course will increase meal energy intake.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy intake</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Std ED Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100% energy density and 133% portion size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inc ED Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>133% energy density and 133% portion size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Std ED and Std PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100% energy density and 100% portion size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Std ED and Inc PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100% energy density and 133% portion size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inc ED and Inc PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>133% energy density and 133% portion size</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inc ED and Std PS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>133% energy density and 100% portion size</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Energy density and portion size feeding study</intervention_name>
    <description>In a crossover design, adults are served breakfast and lunch, 1 day a week for 6 weeks. Breakfast is not varied across weeks. At 4 of the lunch meals, a salad first course will be served that needs to be eaten in its entirety. At these 4 meals the lunch entree will vary in energy density (100% and 133%) and portion size (100% and 133%). At the 2 lunch meals for which no first course is served, the lunch entree will be vary in energy density (100% and 133%) but be the same portion size (133%).</description>
    <arm_group_label>Inc ED Control</arm_group_label>
    <arm_group_label>Inc ED and Inc PS</arm_group_label>
    <arm_group_label>Inc ED and Std PS</arm_group_label>
    <arm_group_label>Std ED Control</arm_group_label>
    <arm_group_label>Std ED and Inc PS</arm_group_label>
    <arm_group_label>Std ED and Std PS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults from Penn State and the surrounding community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently dieting&#xD;
&#xD;
          -  Food allergies&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Barbara J Rolls</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</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 20, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Barbara J. Rolls</investigator_full_name>
    <investigator_title>Professor of Nutritional Sciences and Director of the Laboratory for the Study of Ingestive Behavior</investigator_title>
  </responsible_party>
  <keyword>Feeding behavior</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/NCT01729390
org study id: FoodED501
secondary id: 5R01DK059853-11
nct id: NCT01729390
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this research is to determine whether varying the energy density and portion
      size of the main course will affect meal energy intake after consumption of a first course
      that has previously been shown to enhance satiety. It is hypothesized that increasing either
      the energy density or portion size of the main course will increase meal energy intake after
      consumption of the first course. It is also hypothesized that compared to when a first course
      is consumed, not consuming a first course will increase meal energy intake.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Energy intake
time frame: 6 weeks
measure: Food intake
time frame: 6 weeks
arm group label: Std ED Control
arm group type: Experimental
description: 100% energy density and 133% portion size
arm group label: Inc ED Control
arm group type: Experimental
description: 133% energy density and 133% portion size
arm group label: Std ED and Std PS
arm group type: Experimental
description: 100% energy density and 100% portion size
arm group label: Std ED and Inc PS
arm group type: Experimental
description: 100% energy density and 133% portion size
arm group label: Inc ED and Inc PS
arm group type: Experimental
description: 133% energy density and 133% portion size
arm group label: Inc ED and Std PS
arm group type: Experimental
description: 133% energy density and 100% portion size
intervention type: Other
intervention name: Energy density and portion size feeding study
description: In a crossover design, adults are served breakfast and lunch, 1 day a week for 6 weeks. Breakfast is not varied across weeks. At 4 of the lunch meals, a salad first course will be served that needs to be eaten in its entirety. At these 4 meals the lunch entree will vary in energy density (100% and 133%) and portion size (100% and 133%). At the 2 lunch meals for which no first course is served, the lunch entree will be vary in energy density (100% and 133%) but be the same portion size (133%).
arm group label: Inc ED Control
arm group label: Inc ED and Inc PS
arm group label: Inc ED and Std PS
arm group label: Std ED Control
arm group label: Std ED and Inc PS
arm group label: Std ED and Std PS
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara J Rolls
role: Principal Investigator
affiliation: Penn State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Barbara J. Rolls
investigator title: Professor of Nutritional Sciences and Director of the Laboratory for the Study of Ingestive Behavior