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

NCT01666574 | Completed

• 1 other identifier: PBRC 12029 (Period 2)
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Intake; Satiety

Outcome Measures

Primary Outcomes (1)

• Satiety Impact

  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.

  Baseline to 2 days

Secondary Outcomes (1)

• Impact on food intake at lunch

  Baseline to 2 days

Study Arms (2)

Test cereal 1, Oat-based

EXPERIMENTAL

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; Other: Test Cereal 2, Oat based

Test Cereal 2, Oat based

EXPERIMENTAL

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; Other: Test Cereal 2, Oat based

Interventions

Test cereal 1, Oat-based OTHER

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.

Test Cereal 2, Oat based; Test cereal 1, Oat-based

Test Cereal 2, Oat based OTHER

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.

Test Cereal 2, Oat based; Test cereal 1, Oat-based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• PepsiCo Global R&D: collaborator
• Quaker Oats Company: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)