Effects of a Breakfast and Snack on Cognitive Function in Preadolescents

This study is not yet open for participant recruitment.

Verified November 2012 by University of Arkansas

Sponsor:

Information provided by (Responsible Party):

University of Arkansas

ClinicalTrials.gov Identifier:

NCT01592487

First received: May 3, 2012

Last updated: November 19, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2012
Last Updated Date	November 19, 2012
Start Date ^ICMJE	August 2013
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01592487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
Official Title ^ICMJE	Not Provided
Brief Summary	This study is designed to test how breakfast affects brain function, memory and learning in healthy children. Hypotheses: Based on the results of our initial study and the relevant literature, it is hypothesized that arousal, attention, and performance will be: Greater in those who eat breakfast relative to those who do not; Greater in lean than in overweight children receiving the higher protein breakfast; Greater in fasting lean than fasting overweight children; and Improved following a morning snack in all study groups. Poorer in children with higher stress-related measures (e.g., higher cortisol levels). Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	healthy 4th and 5th graders
Condition ^ICMJE	Brain Function
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Lean BMI BMI in the 25th - 75th percentile Overweight BMI BMI in the 85th - 95th percentile
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	180
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy attending 4th or 5th grade lean BMI or overweight BMI right hand dominance no food allergies eat breakfast at least 4 mornings/week no medications for chronic illness/disorder that may affect outcome (as determined by the PI) Exclusion Criteria: food allergies medications that could affect the outcome left hand dominance
Gender	Both
Ages	9 Years to 11 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01592487
Other Study ID Numbers ^ICMJE	114663
Has Data Monitoring Committee	Yes
Responsible Party	University of Arkansas
Study Sponsor ^ICMJE	University of Arkansas
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Arkansas
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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