Infant Diet Effects on Brain Function and Language Processing (fMRI)
October 15, 2025 updated by: Arkansas Children's Hospital Research Institute
Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Arkansas Children's Nutrition Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
healthy 8-year-old children
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
No groups
IDE used for outcome measurement not intervention
|
IDE used for outcome measurement not intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brain function test
Time Frame: 8 year old
|
8 year old
|
|
Language processing tests
Time Frame: 8 year old
|
8 year old
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiawei Ou, Ph.D., Arkansas Children's Nutrition Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2008
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 14, 2008
First Submitted That Met QC Criteria
August 14, 2008
First Posted (Estimated)
August 15, 2008
Study Record Updates
Last Update Posted (Actual)
October 20, 2025
Last Update Submitted That Met QC Criteria
October 15, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 77556
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.