Effects of Breakfast on Cognitive Processes in Children

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

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.

Official Title
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A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children

Conditions
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Cognitive Function

Intervention / Treatment
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* Other: breakfast cereal
* Other: water


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breakfast cereal<br>breakfast cereal and milk | Other: breakfast cereal<br>* breakfast cereal and milk<br>|
| Placebo Comparator: water<br>water | Other: water<br>* water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Memory and Attention based on results using CDR System |  | 4 hours following breakfast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of Memory and Attention based on results using CDR System |  | 4 hours following breakfast |