NCT01592487

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:

  1. 1.Greater in those who eat breakfast relative to those who do not;
  2. 2.Greater in lean than in overweight children receiving the higher protein breakfast;
  3. 3.Greater in fasting lean than fasting overweight children; and
  4. 4.Improved following a morning snack in all study groups.
  5. 5.Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
  6. 6.Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

May 3, 2012

Last Update Submit

February 11, 2014

Conditions

Brain Function

Study Arms (2)

Lean BMI

BMI in the 25th - 75th percentile

Overweight BMI

BMI in the 85th - 95th percentile

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

healthy 4th and 5th graders

You may qualify if:

  • 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)

You may not qualify if:

  • food allergies
  • medications that could affect the outcome
  • left hand dominance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 7, 2012

Study Start

December 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

US(1)