Brain Fuel - Morning Nutrition and Cognitive Function

NCT ID: NCT03386396

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obese Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High protein/low carbohydrate

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

Group Type EXPERIMENTAL

High protein/low carbohydrate

Intervention Type DIETARY_SUPPLEMENT

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

High carbohydrate/low protein

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

Group Type EXPERIMENTAL

High carbohydrate/low protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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High protein/low carbohydrate

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

Intervention Type DIETARY_SUPPLEMENT

High carbohydrate/low protein

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Larson-Prior, PhD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Nutrition Center

Locations

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Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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206464

Identifier Type: -

Identifier Source: org_study_id

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