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Effects of Breakfast on Cognitive Processes in Children

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ClinicalTrials.gov Identifier: NCT01063894
Recruitment Status : Unknown
Verified February 2010 by Kellogg Company.
Recruitment status was:  Recruiting
First Posted : February 5, 2010
Last Update Posted : February 5, 2010
Sponsor:
Collaborator:
Provident Clinical Research
Information provided by:
Kellogg Company

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

Condition or disease Intervention/treatment Phase
Cognitive Function Other: breakfast cereal Other: water Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
Study Start Date : December 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: breakfast cereal
breakfast cereal and milk
Other: breakfast cereal
breakfast cereal and milk
Placebo Comparator: water
water
Other: water
water



Primary Outcome Measures :
  1. Quality of Memory and Attention based on results using CDR System [ Time Frame: 4 hours following breakfast ]

Secondary Outcome Measures :
  1. Speed of Memory and Attention based on results using CDR System [ Time Frame: 4 hours following breakfast ]


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kevin Maki, Ph.D., Provident Clinical Research & Consulting, Inc.
ClinicalTrials.gov Identifier: NCT01063894     History of Changes
Other Study ID Numbers: PRV-09013
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010