Brain Fuel - Morning Nutrition and Cognitive Function

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Audrey Martinez, MS, RD, LD
  • Phone Number: 501-364-3309

Study Locations

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

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 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

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

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

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
Time Frame: 9-10 years
Standardized testing
9-10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

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 (Actual)

November 28, 2017

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

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)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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

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.

Clinical Trials on Healthy

Clinical Trials on High protein/low carbohydrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe