Effects of a Breakfast and Snack on Cognitive Function in Preadolescents

Brain Function Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01592487
• Other study ID #: 114663
• Status: Withdrawn
• Phase: N/A
• First received: May 3, 2012
• Last updated: February 11, 2014
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Function

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States,