CClinicalTrials.gg
Active, not recruitingNCT00735423Updated Oct 20, 2025

Infant Diet Effects on Brain Function and Language Processing (fMRI)

An observational study in Healthy, sponsored by Arkansas Children's Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 90 Months to 101 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
90 Months to 101 Months
Sex
All
01

Study summary

The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

02

Conditions studied

  • Healthy

Browse trials for

Keywords

  • Healthy children
  • Brain Function
  • Diet
  • Nutrition
  • Language
  • fMRI
  • ERP
  • Behavior
03

In context

Language

63 studies on the registry are indexed under Language; 40 are open to participants now.

This study's planned enrollment of 100 is close to the median of 111 across 12 observational studies indexed under Language.

Browse Language studies →

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
90 Months to 101 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

healthy 8-year-old children

Inclusion criteria

  • Healthy 8-year-old children
  • Full term
  • Birth weight between the 5th - 95th weight-for-age
  • Use of Breast milk, milk-based formula or soy-based formula throughout first year of life
  • English as primary language
  • Right handed first visit
  • BMI between 5th - 95th percentile-for-age

Exclusion criteria

Exclusion Criteria:

  • Children with sleep disorders
  • Children who use certain medications that may interfere with study assessments
  • Illnesses or diseases or conditions that may interfere with study assessments
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)

Groups and cohorts

  • No groups

    IDE used for outcome measurement not intervention

    Device: No intervention

Interventions

  • DeviceNo intervention

    IDE used for outcome measurement not intervention

06

What researchers measure

Primary outcomes

  1. Brain function test

    Time frame: 8 year old

  2. Language processing tests

    Time frame: 8 year old

07

Study locations

1 site
  • Arkansas Children's Nutrition Center
    Little Rock, Arkansas 72202, United States
08

References and documents

Publications

  • Ou X, Andres A, Cleves MA, Pivik RT, Snow JH, Ding Z, Badger TM. Sex-specific association between infant diet and white matter integrity in 8-y-old children. Pediatr Res. 2014 Dec;76(6):535-43. doi: 10.1038/pr.2014.129. Epub 2014 Aug 28. PubMed 25167204 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00735423
Lead sponsor
Arkansas Children's Hospital Research Institute
Responsible party
Sponsor
First posted
Aug 15, 2008
Start date
Aug 2008
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 20, 2025

Study contacts

Xiawei Ou, Ph.D.
principal investigator · Arkansas Children's Nutrition Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion