Effects of Breakfast on Cognitive Processes in Children

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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Other: water; Other: breakfast cereal

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 Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Provident Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: breakfast cereal; breakfast cereal and milk	Other: breakfast cereal; breakfast cereal and milk
Placebo Comparator: water	Other: water; water

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kellogg Company
• Collaborators: Provident Clinical Research
• Investigators: Study Director: Kevin Maki, Ph.D., Provident Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 4, 2010
• First Posted (Estimate): February 5, 2010

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PRV-09013