Brain Fuel - Morning Nutrition and Cognitive Function

Morning Nutrition and Cognitive Function in Preadolescents

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Obese
• Intervention / Treatment: Dietary supplement: High protein/low carbohydrate; Dietary supplement: High carbohydrate/low protein

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.

• Study Type: Interventional
• Enrollment (Estimated): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High protein/low carbohydrate; A breakfast shake will be made with high protein/low carbohydrate mixture.	Dietary supplement: High protein/low carbohydrate; A high protein/low carbohydrate shake will be given to the child.
Experimental: High carbohydrate/low protein; A breakfast shake will be made with high carbohydrate/low protein mixture.	Dietary supplement: High carbohydrate/low protein; A high carbohydrate/low protein shake will be given to the child

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological assessments	Standardized testing	9-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive measures	Brain Lab recordings and fMRI readings	9-10 years

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Investigators: Principal Investigator: Linda Larson-Prior, PhD, Arkansas Children's Nutrition Center

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): January 6, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Carbohydrate-Restricted; Diet, High-Protein; Diet, High-Protein Low-Carbohydrate
• Other Study ID Numbers: 206464

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No