Effects of Breakfast on Cognitive Processes in Children

Kellogg´s

Status: Completed

Conditions: Cognitive Function

Treatments: Other: breakfast cereal; Other: water

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01063894

PRV-09013

Details and patient eligibility

About

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

Full 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.

Enrollment: 291 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups, including a placebo group

breakfast cereal

Experimental group

Description:

breakfast cereal and milk

Treatment:

Other: breakfast cereal

water

Placebo Comparator group

Description:

water

Treatment:

Other: water