Text Size

Effects of Breakfast on Cognitive Processes in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Kellogg Company.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Provident Clinical Research
Information provided by:
Kellogg Company
ClinicalTrials.gov Identifier:
NCT01063894
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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


Condition Intervention
Cognitive Function
 Other: breakfast cereal
Other: water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kellogg Company:

Primary Outcome Measures:
  • Quality of Memory and Attention based on results using CDR System [ Time Frame: 4 hours following breakfast ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speed of Memory and Attention based on results using CDR System [ Time Frame: 4 hours following breakfast ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: December 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: breakfast cereal
breakfast cereal and milk
 Other: breakfast cereal
breakfast cereal and milk
Placebo Comparator: water
water
 Other: water
water

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063894

Contacts
Contact: MarySue Witchger, RD 630-858-4426 mswitchger@providentcrc.com

Locations
United States, Illinois
Provident Clinical Research Recruiting
Addison, Illinois, United States, 60101
Contact: John Marshall, RN     630-617-2003     jmarshall@providentcrc.com    
Principal Investigator: Kathleen Kelley, MD            
Sponsors and Collaborators
Kellogg Company
Provident Clinical Research
Investigators
Study Director: Kevin Maki, Ph.D. Provident Clinical Research
  More Information

No publications provided

Responsible Party: Kevin Maki, Ph.D., Provident Clinical Research & Consulting, Inc.
ClinicalTrials.gov Identifier: NCT01063894     History of Changes
Other Study ID Numbers: PRV-09013
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013