Brain Fuel - Morning Nutrition and Cognitive Function

• Sponsor: Arkansas Children's Hospital Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03386396
• Collaborator: (none)
• Enrollment: 151
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 66.2
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obese; Healthy	Dietary Supplement: High protein/low carbohydrate; Dietary Supplement: High carbohydrate/low protein	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shakeOne group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Morning Nutrition and Cognitive Function in Preadolescents
• Actual Study Start Date: Nov 28, 2017
• Anticipated Primary Completion Date: Jun 4, 2023
• Anticipated Study Completion Date: Jun 4, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Psychological assessments [9-10 years]

   Standardized testing

Secondary Outcome Measures

1. Neurocognitive measures [9-10 years]

   Brain Lab recordings and fMRI readings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 10 Years
• Sexes Eligible for Study: 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:

• Full scale IQ <80

• Children taking medications or having chronic illness/disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Nutrition Center	Little Rock	Arkansas	United States	72203

Sponsors and Collaborators

• Arkansas Children's Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arkansas Children's Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03386396
• Other Study ID Numbers: 206464
• First Posted: Dec 29, 2017
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 5, 2022