- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592487
Effects of a Breakfast and Snack on Cognitive Function in Preadolescents
February 11, 2014 updated by: University of Arkansas
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:
- Greater in those who eat breakfast relative to those who do not;
- Greater in lean than in overweight children receiving the higher protein breakfast;
- Greater in fasting lean than fasting overweight children; and
- Improved following a morning snack in all study groups.
- Poorer in children with higher stress-related measures (e.g., higher cortisol levels).
- Heart rate will be lower in fasting relative to fed participants, and across groups will be higher in overweight children.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Nutrition Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy 4th and 5th graders
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lean BMI
BMI in the 25th - 75th percentile
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Overweight BMI
BMI in the 85th - 95th percentile
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 3, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
February 12, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 114663
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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