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Completed

NCT Number: NCT01372683

Oat Breakfast Satiety Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary Intervention

Other

Comparison of oat based breakfast cereals

Primary outcomes

  1. Area under the curve (AUC) of appetite and satiety

    Time frame: 4 hours

Secondary outcomes

  1. Area under the curve for subjective energy measures

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Collaborators

  • Pennington Biomedical Research Center

Registry information

Official study title

The Effect of Oat Based Breakfast Cereals on Satiety

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2011
Registry last updated
Dec 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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