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

This study is currently recruiting participants.
Verified May 2013 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:
NCT01666561
First received: August 14, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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: up to day 3 ] [ Designated as safety issue: No ]
    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.


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

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.

 Other: Breakfast Test Cereal 1, Oat based
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.
Other: Breakfast Test Cereal 2, Oat-based
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.
Other: Ready-to-eat cereal
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.
Experimental: Breakfast Test Cereal 2, Oat-based

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.

 Other: Breakfast Test Cereal 1, Oat based
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.
Other: Breakfast Test Cereal 2, Oat-based
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.
Other: Ready-to-eat cereal
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.
Experimental: Ready-to-eat cereal

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.

 Other: Breakfast Test Cereal 1, Oat based
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.
Other: Breakfast Test Cereal 2, Oat-based
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.
Other: Ready-to-eat cereal
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.

Detailed Description:

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.

  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: NCT01666561

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
Frank Greenway
PepsiCo Global R&D
Quaker Oats
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01666561     History of Changes
Other Study ID Numbers: PBRC12029 (Period 1) Quaker A
Study First Received: August 14, 2012
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013