<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/NCT01666574</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12029 (Period 2)</org_study_id>
    <nct_id>NCT01666574</nct_id>
  </id_info>
  <brief_title>The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake</brief_title>
  <official_title>The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quaker Oats Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine if two breakfasts of equivalent calories, an oat based breakfast&#xD;
      cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also&#xD;
      determine if the two calorically equivalent oat-based breakfast cereals give different&#xD;
      caloric intakes at a lunch meal that participants will eat to their satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older&#xD;
      will be enrolled to investigate the satiety and food intake at lunch after a breakfast&#xD;
      consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual&#xD;
      analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120,&#xD;
      180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until&#xD;
      satisfied. The subjects will have the two breakfasts in a balanced and random order and the&#xD;
      two meal tests will be separated by at least a week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satiety Impact</measure>
    <time_frame>Baseline to 2 days</time_frame>
    <description>Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal. Area under the curve (AUC) of appetite and satiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on food intake at lunch</measure>
    <time_frame>Baseline to 2 days</time_frame>
    <description>You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day.&#xD;
Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Food Intake</condition>
  <condition>Satiety</condition>
  <arm_group>
    <arm_group_label>Test cereal 1, Oat-based</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based cereal will cause people to eat less at lunch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Cereal 2, Oat based</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based ready-to-eat cereal will cause people to eat less at lunch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test cereal 1, Oat-based</intervention_name>
    <description>The study design is a lunch that will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.</description>
    <arm_group_label>Test Cereal 2, Oat based</arm_group_label>
    <arm_group_label>Test cereal 1, Oat-based</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test Cereal 2, Oat based</intervention_name>
    <description>The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week. A lunch will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.</description>
    <arm_group_label>Test Cereal 2, Oat based</arm_group_label>
    <arm_group_label>Test cereal 1, Oat-based</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older and are healthy.&#xD;
&#xD;
          -  Taking no regular medications other than birth control or hormone replacement therapy.&#xD;
&#xD;
          -  Are willing to use an effective method of birth control if you are capable of bearing&#xD;
             children. Acceptable methods include abstinence, barrier methods, intrauterine&#xD;
             devices, and hormonal methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are a woman who is pregnant or nursing a baby.&#xD;
&#xD;
          -  Have gained or lost 8.8 pounds or more in the last 3 months.&#xD;
&#xD;
          -  Have diabetes or a fasting blood sugar over 126 mg/dL.&#xD;
&#xD;
          -  Have a score of 14 or greater on the restraint scale of the 3-factor eating&#xD;
             questionnaire (a questionnaire which will be given to you by the study staff).&#xD;
&#xD;
          -  Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>December 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Frank Greenway</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT01666574
org study id: PBRC 12029 (Period 2)
nct id: NCT01666574
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is to determine if two breakfasts of equivalent calories, an oat based breakfast
      cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also
      determine if the two calorically equivalent oat-based breakfast cereals give different
      caloric intakes at a lunch meal that participants will eat to their satisfaction.
The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older
      will be enrolled to investigate the satiety and food intake at lunch after a breakfast
      consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual
      analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120,
      180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until
      satisfied. The subjects will have the two breakfasts in a balanced and random order and the
      two meal tests will be separated by at least a week.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Satiety Impact
time frame: Baseline to 2 days
description: Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal. Area under the curve (AUC) of appetite and satiety.
measure: Impact on food intake at lunch
time frame: Baseline to 2 days
description: You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day.
Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures
arm group label: Test cereal 1, Oat-based
arm group type: Experimental
description: The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based cereal will cause people to eat less at lunch.
arm group label: Test Cereal 2, Oat based
arm group type: Experimental
description: The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based ready-to-eat cereal will cause people to eat less at lunch.
intervention type: Other
intervention name: Test cereal 1, Oat-based
description: The study design is a lunch that will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
arm group label: Test Cereal 2, Oat based
arm group label: Test cereal 1, Oat-based
intervention type: Other
intervention name: Test Cereal 2, Oat based
description: The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week. A lunch will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
arm group label: Test Cereal 2, Oat based
arm group label: Test cereal 1, Oat-based
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator