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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01666574
Other study ID # PBRC 12029 (Period 2)
Secondary ID
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

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date July 2013
Est. primary completion date June 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, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Pennington Biomedical Research Center 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 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 No
Secondary Impact on food intake at lunch You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day.
Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures
Baseline to 2 days No
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