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

Not Applicable

Completed

• Conditions: Food Intake; Satiety
• Interventions: Other: Breakfast Test Cereal 1, Oat based; Other: Breakfast Test Cereal 2, Oat-based; Other: Ready-to-eat cereal

• Registration Number: NCT01666561
• Lead Sponsor: Frank Greenway

Brief 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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breakfast Test Cereal 1, Oat based	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.
Breakfast Test Cereal 1, Oat based	Breakfast Test Cereal 2, 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.
Breakfast Test Cereal 2, Oat-based	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.
Breakfast Test Cereal 1, Oat based	Ready-to-eat cereal	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.
Breakfast Test Cereal 2, Oat-based	Ready-to-eat cereal	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.
Ready-to-eat cereal	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.
Breakfast Test Cereal 2, Oat-based	Breakfast Test Cereal 1, 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.
Ready-to-eat cereal	Breakfast Test Cereal 1, Oat based	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.
Ready-to-eat cereal	Breakfast Test Cereal 2, Oat-based	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.

Primary Outcome Measures

Name	Time	Method
Satiety Impact	up to day 3	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.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States