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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This study has been withdrawn prior to enrollment.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
  Purpose

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.

Condition
Brain Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Arkansas:

Enrollment: 0
Study Start Date: December 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lean BMI
BMI in the 25th - 75th percentile
Overweight BMI
BMI in the 85th - 95th percentile

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy 4th and 5th graders
Criteria

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
  Contacts and Locations
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): NCT01592487


Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01592487     History of Changes
Other Study ID Numbers: 114663
First Submitted: May 3, 2012
First Posted: May 7, 2012
Last Update Posted: February 12, 2014
Last Verified: February 2014