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The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake

This study is currently recruiting participants.
Verified August 2012 by Pennington Biomedical Research Center
Sponsor:
Collaborators:
PepsiCo Global R&D
Quaker Oats
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01666574
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Food Intake
Satiety
 Other: Test cereal 1, Oat-based
Other: Test Cereal 2, Oat based

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Satiety Impact [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Impact on food intake at lunch [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 48
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test cereal 1, Oat-based
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.
 Other: Test cereal 1, Oat-based
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.
Other: Test Cereal 2, Oat based
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.
Experimental: Test Cereal 2, Oat based
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.
 Other: Test cereal 1, Oat-based
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.
Other: Test Cereal 2, Oat based
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older and are healthy.
  • Taking no regular medications other than birth control or hormone replacement therapy.
  • Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.

Exclusion Criteria:

  • Are a woman who is pregnant or nursing a baby.
  • Have gained or lost 8.8 pounds or more in the last 3 months.
  • Have diabetes or a fasting blood sugar over 126 mg/dL.
  • Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
  • Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666574

Contacts
Contact: recruiters 225-763-3000 recruiters@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: recruiters     225-763-3000     doctors@pbrc.edu    
Principal Investigator: Frank Greenway, MD            
Sub-Investigator: Corby Martin, PhD            
Sub-Investigator: Alok Gupta, MD            
Sponsors and Collaborators
Pennington Biomedical Research Center
PepsiCo Global R&D
Quaker Oats
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01666574     History of Changes
Other Study ID Numbers: PBRC12029 (Period 2)
Study First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013