<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/NCT01666561</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12029 (Period 1)</org_study_id>
    <nct_id>NCT01666561</nct_id>
  </id_info>
  <brief_title>The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.</brief_title>
  <acronym>Quaker A</acronym>
  <official_title>The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Frank Greenway</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>
      To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an&#xD;
      equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety&#xD;
      over the 4 hour period following breakfast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be randomly assigned to one of these three breakfasts and then given a&#xD;
      Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60,&#xD;
      120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week&#xD;
      to repeat the breakfast test.&#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">July 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satiety Impact</measure>
    <time_frame>up to day 3</time_frame>
    <description>Breakfast containing of oat-based breakfast cereal will cause people to feel more satiated compared to a breakfast containing of ready-to-eat oat-based breakfast cereal. Appetite and satiety will be measured with a Visual Analog Scale.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Food Intake</condition>
  <condition>Satiety</condition>
  <arm_group>
    <arm_group_label>Breakfast Test Cereal 1, Oat based</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test cereal 1, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:&#xD;
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast Test Cereal 2, Oat-based</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test Cereal 2, Oat-based breakfast cereal. You will be randomly presented with a breakfast consisting of either:&#xD;
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat oat brand cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ready-to-eat cereal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ready-to-eat cereal, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:&#xD;
one Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast Test Cereal 1, Oat based</intervention_name>
    <description>The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (a) one serving of oat based breakfast cereal 1.</description>
    <arm_group_label>Breakfast Test Cereal 1, Oat based</arm_group_label>
    <arm_group_label>Breakfast Test Cereal 2, Oat-based</arm_group_label>
    <arm_group_label>Ready-to-eat cereal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast Test Cereal 2, Oat-based</intervention_name>
    <description>The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (b) an equicaloric amount of Oat based breakfast cereal 2.</description>
    <arm_group_label>Breakfast Test Cereal 1, Oat based</arm_group_label>
    <arm_group_label>Breakfast Test Cereal 2, Oat-based</arm_group_label>
    <arm_group_label>Ready-to-eat cereal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ready-to-eat cereal</intervention_name>
    <description>The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (c) an equicaloric amount of the ready-to-eat cold cereal.</description>
    <arm_group_label>Breakfast Test Cereal 1, Oat based</arm_group_label>
    <arm_group_label>Breakfast Test Cereal 2, Oat-based</arm_group_label>
    <arm_group_label>Ready-to-eat cereal</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 15, 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>Sponsor-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/NCT01666561
org study id: PBRC 12029 (Period 1)
nct id: NCT01666561
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an
      equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety
      over the 4 hour period following breakfast.
The subjects will be randomly assigned to one of these three breakfasts and then given a
      Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60,
      120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week
      to repeat the breakfast test.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Satiety Impact
time frame: up to day 3
description: Breakfast containing of oat-based breakfast cereal will cause people to feel more satiated compared to a breakfast containing of ready-to-eat oat-based breakfast cereal. Appetite and satiety will be measured with a Visual Analog Scale.
arm group label: Breakfast Test Cereal 1, Oat based
arm group type: Experimental
description: Test cereal 1, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.
arm group label: Breakfast Test Cereal 2, Oat-based
arm group type: Experimental
description: Test Cereal 2, Oat-based breakfast cereal. You will be randomly presented with a breakfast consisting of either:
Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat oat brand cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.
arm group label: Ready-to-eat cereal
arm group type: Experimental
description: Ready-to-eat cereal, Oat based breakfast cereal- you will be randomly presented with a breakfast consisting of either:
one Oat-based breakfast cereal with lactose-free, fat-free milk to drink or ready-to-eat cereal in lactose-free, fat -free milk with water to drink. Then you will complete a visual analog scale at 30, 60, 120. 180, and 240 minutes following the start of breakfast meal.
intervention type: Other
intervention name: Breakfast Test Cereal 1, Oat based
description: The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (a) one serving of oat based breakfast cereal 1.
arm group label: Breakfast Test Cereal 1, Oat based
arm group label: Breakfast Test Cereal 2, Oat-based
arm group label: Ready-to-eat cereal
intervention type: Other
intervention name: Breakfast Test Cereal 2, Oat-based
description: The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (b) an equicaloric amount of Oat based breakfast cereal 2.
arm group label: Breakfast Test Cereal 1, Oat based
arm group label: Breakfast Test Cereal 2, Oat-based
arm group label: Ready-to-eat cereal
intervention type: Other
intervention name: Ready-to-eat cereal
description: The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (c) an equicaloric amount of the ready-to-eat cold cereal.
arm group label: Breakfast Test Cereal 1, Oat based
arm group label: Breakfast Test Cereal 2, Oat-based
arm group label: Ready-to-eat cereal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator