NCT00735423

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2008

Longer than P75 for all trials

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 Progress97%
Aug 2008Dec 2026

Study Start

First participant enrolled

August 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
17.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

17.8 years

First QC Date

August 14, 2008

Last Update Submit

October 15, 2025

Conditions

Healthy

Keywords

Healthy childrenBrain FunctionDietNutritionLanguagefMRIERPBehavior

Outcome Measures

Primary Outcomes (2)

  • Brain function test

    8 year old

  • Language processing tests

    8 year old

Study Arms (1)

No groups

IDE used for outcome measurement not intervention

Device: No intervention

Interventions

No interventionDEVICE

IDE used for outcome measurement not intervention

No groups

Eligibility Criteria

Age90 Months - 101 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

healthy 8-year-old children

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • 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.

    PMID: 25167204DERIVED

MeSH Terms

Conditions

LanguageBehavior

Condition Hierarchy (Ancestors)

Communication

Study Officials

  • Xiawei Ou, Ph.D.

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)