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Effects of Breakfast on Cognitive Processes in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01063894
Enrollment
291
Registered
2010-02-05
Start date
2009-12-31
Completion date
2010-04-30
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function

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.

Interventions

breakfast cereal and milk

OTHERwater

water

Sponsors

Provident Clinical Research
CollaboratorOTHER
Kellogg Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Quality of Memory and Attention based on results using CDR System4 hours following breakfast

Secondary

MeasureTime frame
Speed of Memory and Attention based on results using CDR System4 hours following breakfast

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026