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

Satiety Clinical Trial

— Quaker A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666561
• Other study ID #: PBRC 12029 (Period 1)
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: December 17, 2015
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Food Intake
• Satiety

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Frank Greenway	PepsiCo Global R&D, Quaker Oats Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satiety Impact	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.	up to day 3	No