Effects of Breakfast on Cognitive Processes in Children

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Other: breakfast cereal; Other: water

• Registration Number: NCT01063894
• Lead Sponsor: Kellogg Company

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-08
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breakfast cereal	breakfast cereal	breakfast cereal and milk
water	water	water

Primary Outcome Measures

Name	Time	Method
Quality of Memory and Attention based on results using CDR System	4 hours following breakfast

Secondary Outcome Measures

Name	Time	Method
Speed of Memory and Attention based on results using CDR System	4 hours following breakfast

Trial Locations

Locations (1)

Provident Clinical Research; 🇺🇸 Addison, Illinois, United States