Oat Breakfast Satiety Study

Subjective Appetite and Satiety Clinical Trial

Official title:

The Effect of Oat Based Breakfast Cereals on Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372683
• Other study ID #: PEP 1103
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2011
• Last updated: December 19, 2011
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.

Description:

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• 18 years of age or older

• Healthy

• Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children

Exclusion Criteria:

• Women who are pregnant or nursing

• Gain or loss of > 4kg in the last 3 months.

• Diabetes mellitus (fasting glucose >126 mg/dL)

• Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14

• Allergy to any of the foods used for the test breakfasts (oats or milk)

Related Conditions & MeSH terms

• Subjective Appetite and Satiety
• Subjective Energy Levels

Intervention

Other:
• Dietary Intervention
Comparison of oat based breakfast cereals

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of appetite and satiety		4 hours
Secondary	Area under the curve for subjective energy measures		4 hours