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Effects of a Breakfast and Snack on Cognitive Function in Preadolescents

This study has been withdrawn prior to enrollment.
(Study never started, and there are no plans to initiate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592487
First Posted: May 7, 2012
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
May 3, 2012
May 7, 2012
February 12, 2014
December 2013
December 2013   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01592487 on ClinicalTrials.gov Archive Site
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Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
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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:

  1. Greater in those who eat breakfast relative to those who do not;
  2. Greater in lean than in overweight children receiving the higher protein breakfast;
  3. Greater in fasting lean than fasting overweight children; and
  4. Improved following a morning snack in all study groups.
  5. Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
  6. Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
healthy 4th and 5th graders
Brain Function
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  • Lean BMI
    BMI in the 25th - 75th percentile
  • Overweight BMI
    BMI in the 85th - 95th percentile
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
9 Years to 11 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592487
114663
Yes
Not Provided
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University of Arkansas
University of Arkansas
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Not Provided
University of Arkansas
February 2014