Oat Breakfast Satiety Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Oat Based Breakfast Cereals on Satiety

Conditions
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Subjective Appetite and Satiety, Subjective Energy Levels

Intervention / Treatment
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* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test cereal 1<br>Oat based breakfast cereal | Other: Dietary Intervention<br>* Comparison of oat based breakfast cereals<br>|
| Experimental: Test cereal 2<br>2nd Oat based breakfast cereal | Other: Dietary Intervention<br>* Comparison of oat based breakfast cereals<br>|
| Experimental: Leading oat based RTE cereal<br>3rd oat based breakfast cereal | Other: Dietary Intervention<br>* Comparison of oat based breakfast cereals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of appetite and satiety |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for subjective energy measures |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satiety, Appetite, Subjective energy, Oats