Infant Diet Effects on Brain Function and Language Proces... | NCT00735423

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

NCT00735423

Sponsor

Arkansas Children's Hospital Research Institute

Status

Active, not recruiting

Last Update Posted

Oct 20, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Healthy

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Aug 14, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2025

Last Update Posted Date

Oct 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No groups		IDE used for outcome measurement not intervention	Device: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Device	IDE used for outcome measurement not intervention	No groups

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain function test		8 year old
Language processing tests		8 year old

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

90 Months

Maximum Age

101 Months

Standard Ages

Child

Study Population

healthy 8-year-old children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiawei Ou, Ph.D.	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25167204	Derived	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.

ID	Term
D007802	Language
D001519	Behavior