NCT03386396

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Nov 2017Dec 2026

Study Start

First participant enrolled

November 28, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

6.1 years

First QC Date

December 6, 2017

Last Update Submit

October 15, 2025

Conditions

ObeseHealthy

Outcome Measures

Primary Outcomes (1)

  • Psychological assessments

    Standardized testing

    9-10 years

Secondary Outcomes (1)

  • Neurocognitive measures

    9-10 years

Study Arms (2)

High protein/low carbohydrate

EXPERIMENTAL

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

Dietary Supplement: High protein/low carbohydrate

High carbohydrate/low protein

EXPERIMENTAL

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

Dietary Supplement: High carbohydrate/low protein

Interventions

High protein/low carbohydrateDIETARY_SUPPLEMENT

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

High protein/low carbohydrate
High carbohydrate/low proteinDIETARY_SUPPLEMENT

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

High carbohydrate/low protein

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Linda Larson-Prior, PhD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 29, 2017

Study Start

November 28, 2017

Primary Completion

January 6, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)