Oat Breakfast Satiety Study

December 19, 2011 updated by: PepsiCo Global R&D

The Effect of Oat Based Breakfast Cereals on Satiety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve for subjective energy measures
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Collaborators

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Frank Greenway, MD, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

December 20, 2011

Last Update Submitted That Met QC Criteria

December 19, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP 1103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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