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

NCT ID: NCT00735423

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No groups

IDE used for outcome measurement not intervention

No intervention

Intervention Type DEVICE

IDE used for outcome measurement not intervention

Interventions

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No intervention

IDE used for outcome measurement not intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

90 Months

Maximum Eligible Age

101 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiawei Ou, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Nutrition Center

Locations

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Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25167204 (View on PubMed)

Other Identifiers

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77556

Identifier Type: -

Identifier Source: org_study_id

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