Effects of Breakfast on Cognitive Processes in Children

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

NA

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-04-30

Brief Summary

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The objective of this study is to test the effects of breakfast on cognitive processing ability in children.

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Detailed Description

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Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.

Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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breakfast cereal

breakfast cereal and milk

Group Type EXPERIMENTAL

breakfast cereal

Intervention Type OTHER

breakfast cereal and milk

water

Group Type PLACEBO_COMPARATOR

water

Intervention Type OTHER

water

Interventions

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breakfast cereal

breakfast cereal and milk

Intervention Type OTHER

water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
* Provision of assent by subject
* Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators

Exclusion Criteria

* Diagnosis of attention deficit disorder, with or without hyperactivity
* A diagnosis of diabetes mellitus
* Acute illness or use of antibiotics within 5 days of visit
* Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
* Known sensitivity or allergy to any ingredients of the study product
* Use of any psychotropic medication within 4 weeks
* Subject did not previously participate in an earlier trial with the same study products
* Exposure to investigational agent within 30 days.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes