Effects of Breakfast on Cognitive Processes in Children

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063894
• Other study ID #: PRV-09013
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2015
• Source: Kellogg Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Other:
• breakfast cereal
breakfast cereal and milk
• water
water

Locations

Country	Name	City	State
United States	Provident Clinical Research	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Kellogg Company	Provident Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Memory and Attention based on results using CDR System		4 hours following breakfast
Secondary	Speed of Memory and Attention based on results using CDR System		4 hours following breakfast