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Active, not recruitingNCT03386396Updated Oct 20, 2025

Brain Fuel - Morning Nutrition and Cognitive Function

An interventional study of High protein/low carbohydrate and High carbohydrate/low protein in Obese and Healthy, sponsored by Arkansas Children's Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 9 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
9 Years to 10 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Obese
  • Healthy

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03

Who can participate

Ages eligible
9 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Full scale IQ \<80
  • Children taking medications or having chronic illness/disorders
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
151 participants (estimated)

Study arms

  • Experimental
    High protein/low carbohydrate

    A breakfast shake will be made with high protein/low carbohydrate mixture.

    Dietary Supplement: High protein/low carbohydrate

  • Experimental
    High carbohydrate/low protein

    A breakfast shake will be made with high carbohydrate/low protein mixture.

    Dietary Supplement: High carbohydrate/low protein

Interventions

  • Dietary supplementHigh protein/low carbohydrate

    A high protein/low carbohydrate shake will be given to the child.

  • Dietary supplementHigh carbohydrate/low protein

    A high carbohydrate/low protein shake will be given to the child

05

What researchers measure

Primary outcomes

  1. Psychological assessments

    Standardized testing

    Time frame: 9-10 years

Secondary outcomes

  1. Neurocognitive measures

    Brain Lab recordings and fMRI readings

    Time frame: 9-10 years

06

Study locations

1 site
  • Arkansas Children's Nutrition Center
    Little Rock, Arkansas 72203, United States
07

Registry details

Key details

Study ID
NCT03386396
Lead sponsor
Arkansas Children's Hospital Research Institute
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Nov 28, 2017
Primary completion
Jan 6, 2024
Completion
Dec 2026 (estimated)
Last update
Oct 20, 2025

Study contacts

Linda Larson-Prior, PhD
principal investigator · Arkansas Children's Nutrition Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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