<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/NCT04404998</url>
  </required_header>
  <id_info>
    <org_study_id>FoodED601</org_study_id>
    <nct_id>NCT04404998</nct_id>
  </id_info>
  <brief_title>The Influence of Energy Density and Information on Meal Intake in Adults</brief_title>
  <official_title>Lunch Meal Study for Men and Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to gain a better understanding of how energy density and&#xD;
      cognitive framing of satiation using food information can influence consumption at a meal.&#xD;
      This study also aims to investigate the influence of energy density and food information on&#xD;
      sensory specific satiety (the decline in the subjective pleasantness of a food as it is&#xD;
      eaten).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Issues with recruitment due to COVID 19&#xD;
  </why_stopped>
  <start_date type="Actual">August 3, 2021</start_date>
  <completion_date type="Actual">November 8, 2021</completion_date>
  <primary_completion_date type="Actual">November 8, 2021</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in food intake by weight</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Weight of food consumed measured in grams (g)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in energy intake</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Energy content of food consumed measured in kilocalories (kcal)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in palatability rating of food samples</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference between post-meal and pre-meal palatability of the food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prospective consumption rating of food samples</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference between post-meal and pre-meal prospective consumption of food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hunger rating</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference between post-meal and pre-meal hunger measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fullness rating</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference between post-meal and pre-meal fullness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in test meal prospective consumption rating</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference in prospective consumption measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in test meal fillingness rating</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference in fillingness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in test meal palatability rating</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference in palatability of the test meal measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimation of proportion of test meal consumed</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference in estimation of proportion of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimation of energy content of test meal consumed</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Difference in estimation of energy content of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>Lower Energy Density &amp; Lower Satiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with lower energy density and lower satiation information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower Energy Density &amp; Higher Satiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with lower energy density and higher satiation information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher Energy Density &amp; Lower Satiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with higher energy density and lower satiation information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher Energy Density &amp; Higher Satiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with higher energy density and higher satiation information</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower Energy Density</intervention_name>
    <description>Test meal with lower energy density</description>
    <arm_group_label>Lower Energy Density &amp; Higher Satiation</arm_group_label>
    <arm_group_label>Lower Energy Density &amp; Lower Satiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Higher Energy Density</intervention_name>
    <description>Test meal with higher energy density</description>
    <arm_group_label>Higher Energy Density &amp; Higher Satiation</arm_group_label>
    <arm_group_label>Higher Energy Density &amp; Lower Satiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower Satiation</intervention_name>
    <description>Information on lower satiation</description>
    <arm_group_label>Higher Energy Density &amp; Lower Satiation</arm_group_label>
    <arm_group_label>Lower Energy Density &amp; Lower Satiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Higher Satiation</intervention_name>
    <description>Information on higher satiation</description>
    <arm_group_label>Higher Energy Density &amp; Higher Satiation</arm_group_label>
    <arm_group_label>Lower Energy Density &amp; Higher Satiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to attend all test meals&#xD;
&#xD;
          -  Be fully vaccinated against COVID-19&#xD;
&#xD;
          -  Regularly eat 3 meals/day&#xD;
&#xD;
          -  Being willing to avoid alcohol the day before and during test days&#xD;
&#xD;
          -  Have a body mass index greater than 18.0 kg/meters squared&#xD;
&#xD;
          -  Being willing to refrain from eating after 10 pm the evening before test sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being a smoker&#xD;
&#xD;
          -  Being an athlete in training&#xD;
&#xD;
          -  Being pregnant or breastfeeding at the time of screening&#xD;
&#xD;
          -  Have taken prescription or non-prescription drugs that may affect appetite or food&#xD;
             intake within the last 3 months&#xD;
&#xD;
          -  Dislike or inability to eat the test foods&#xD;
&#xD;
          -  Currently dieting to gain or lose weight&#xD;
&#xD;
          -  Have a health condition that affects appetite&#xD;
&#xD;
          -  Have participated in a similar study in our lab in the past year&#xD;
&#xD;
          -  Being a student, faculty, or staff member in nutritional sciences or psychology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University</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>December 2021</verification_date>
  <study_first_submitted>March 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>December 8, 2021</last_update_submitted>
  <last_update_submitted_qc>December 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2021</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 Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior</investigator_title>
  </responsible_party>
  <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/NCT04404998
org study id: FoodED601
nct id: NCT04404998
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to gain a better understanding of how energy density and
      cognitive framing of satiation using food information can influence consumption at a meal.
      This study also aims to investigate the influence of energy density and food information on
      sensory specific satiety (the decline in the subjective pleasantness of a food as it is
      eaten).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in food intake by weight
time frame: Weeks 1, 2, 3, 4
description: Weight of food consumed measured in grams (g)
measure: Change in energy intake
time frame: Weeks 1, 2, 3, 4
description: Energy content of food consumed measured in kilocalories (kcal)
measure: Change in palatability rating of food samples
time frame: Weeks 1, 2, 3, 4
description: Difference between post-meal and pre-meal palatability of the food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
measure: Change in prospective consumption rating of food samples
time frame: Weeks 1, 2, 3, 4
description: Difference between post-meal and pre-meal prospective consumption of food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
measure: Change in hunger rating
time frame: Weeks 1, 2, 3, 4
description: Difference between post-meal and pre-meal hunger measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in fullness rating
time frame: Weeks 1, 2, 3, 4
description: Difference between post-meal and pre-meal fullness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in test meal prospective consumption rating
time frame: Weeks 1, 2, 3, 4
description: Difference in prospective consumption measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in test meal fillingness rating
time frame: Weeks 1, 2, 3, 4
description: Difference in fillingness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in test meal palatability rating
time frame: Weeks 1, 2, 3, 4
description: Difference in palatability of the test meal measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in estimation of proportion of test meal consumed
time frame: Weeks 1, 2, 3, 4
description: Difference in estimation of proportion of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
measure: Change in estimation of energy content of test meal consumed
time frame: Weeks 1, 2, 3, 4
description: Difference in estimation of energy content of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
arm group label: Lower Energy Density & Lower Satiation
arm group type: Experimental
description: Test meal with lower energy density and lower satiation information
arm group label: Lower Energy Density & Higher Satiation
arm group type: Experimental
description: Test meal with lower energy density and higher satiation information
arm group label: Higher Energy Density & Lower Satiation
arm group type: Experimental
description: Test meal with higher energy density and lower satiation information
arm group label: Higher Energy Density & Higher Satiation
arm group type: Experimental
description: Test meal with higher energy density and higher satiation information
intervention type: Other
intervention name: Lower Energy Density
description: Test meal with lower energy density
arm group label: Lower Energy Density & Higher Satiation
arm group label: Lower Energy Density & Lower Satiation
intervention type: Other
intervention name: Higher Energy Density
description: Test meal with higher energy density
arm group label: Higher Energy Density & Higher Satiation
arm group label: Higher Energy Density & Lower Satiation
intervention type: Other
intervention name: Lower Satiation
description: Information on lower satiation
arm group label: Higher Energy Density & Lower Satiation
arm group label: Lower Energy Density & Lower Satiation
intervention type: Other
intervention name: Higher Satiation
description: Information on higher satiation
arm group label: Higher Energy Density & Higher Satiation
arm group label: Lower Energy Density & Higher Satiation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Barbara J. Rolls
investigator title: Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior
sharing ipd: No