Oat Breakfast Satiety Study

PepsiCo

Status and phase: Completed; Phase 4

Conditions: Subjective Energy Levels; Subjective Appetite and Satiety

Treatments: Other: Dietary Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01372683

PEP 1103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

96 participants in 3 patient groups

Test cereal 1

Experimental group

Description:

Oat based breakfast cereal

Treatment:

Other: Dietary Intervention

Test cereal 2

Experimental group

Description:

2nd Oat based breakfast cereal

Treatment:

Other: Dietary Intervention

Leading oat based RTE cereal

Experimental group

Description:

3rd oat based breakfast cereal

Treatment:

Other: Dietary Intervention