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

NCT ID: NCT01666574

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Food Intake Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test cereal 1, Oat-based

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.

Group Type EXPERIMENTAL

Test cereal 1, Oat-based

Intervention Type 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

Intervention Type 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

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.

Group Type EXPERIMENTAL

Test cereal 1, Oat-based

Intervention Type 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

Intervention Type 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.

Interventions

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Test cereal 1, Oat-based

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.

Intervention Type OTHER

Test Cereal 2, Oat based

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role collaborator

Quaker Oats Company

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 12029 (Period 2)

Identifier Type: -

Identifier Source: org_study_id