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NCT03386396 Clinical Trial

Brain Fuel - Morning Nutrition and Cognitive Function

Healthy Clinical Trial

Official title:
Morning Nutrition and Cognitive Function in Preadolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03386396
Other study ID # 206464
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 28, 2017
Est. completion date June 2024

Study information
Verified date February 2024
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will help us learn more about how what a child eats can affect how their brain works.

Description:

Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 151
Est. completion date June 2024
Est. primary completion date January 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 10 Years
Eligibility Inclusion Criteria: - 9-10 yr, 3rd to 5th grade - Obese - Right hand dominance - Report eating breakfast at least 4 days/week - Able to hear at least 20dB stimulus - Visual acuity must be at least 20/40 - Biological mother available to attend visit Exclusion Criteria: - Full scale IQ <80 - Children taking medications or having chronic illness/disorders

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• High protein/low carbohydrate
A high protein/low carbohydrate shake will be given to the child.
• High carbohydrate/low protein
A high carbohydrate/low protein shake will be given to the child

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

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Psychological assessments Standardized testing 9-10 years
Secondary Neurocognitive measures Brain Lab recordings and fMRI readings 9-10 years
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