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

Pennington Biomedical Research Center

Status: Completed

Conditions: Satiety; Food Intake

Treatments: Other: Test cereal 1, Oat-based; Other: Test Cereal 2, Oat based

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01666574

PBRC 12029 (Period 2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Test cereal 1, Oat-based

Experimental group

Description:

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.

Treatment:

Other: Test cereal 1, Oat-based

Other: Test Cereal 2, Oat based

Test Cereal 2, Oat based

Experimental group

Description:

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.

Treatment:

Other: Test cereal 1, Oat-based

Other: Test Cereal 2, Oat based