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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01592487
First received: May 3, 2012
Last updated: February 11, 2014
Last verified: February 2014
  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

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592487

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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01592487     History of Changes
Other Study ID Numbers: 114663
Study First Received: May 3, 2012
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014