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Oat Breakfast Satiety Study

NCT ID: NCT01372683

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

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.

Conditions

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Subjective Appetite and Satiety Subjective Energy Levels

Keywords

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Appetite Satiety Subjective energy Oats

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test cereal 1

Oat based breakfast cereal

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Comparison of oat based breakfast cereals

Test cereal 2

2nd Oat based breakfast cereal

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Comparison of oat based breakfast cereals

Leading oat based RTE cereal

3rd oat based breakfast cereal

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

Comparison of oat based breakfast cereals

Interventions

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Dietary Intervention

Comparison of oat based breakfast cereals

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PEP 1103

Identifier Type: -

Identifier Source: org_study_id