HealthyNCT00735423
Infant Diet Effects on Brain Function and Language Processing (fMRI)
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 90 to 101 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 to 101 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy 8-year-old children
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- No intervention
- Keywords
- Healthy children, Brain Function, Diet, Nutrition, Language, fMRI, ERP, Behavior
- Medical subject headings
- Language, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
IDE used for outcome measurement not intervention
| Study group | Role | What they receive |
|---|---|---|
| No groups | IDE used for outcome measurement not intervention Receives: Device: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain function test
Measured: 8 year old
Language processing tests
Measured: 8 year old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiawei Ou, Ph.D., Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735423
- Sponsor's protocol ID
- 77556
- Status last verified
- Oct 2025
- First submitted
- 14 Aug 2008
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures
- ClinicalTrials.gov ID
- NCT00735423
- Acronym / sponsor ID
- 77556
- Conditions
- Healthy
- Keywords
- Healthy children, Brain Function, Diet, Nutrition, Language, fMRI, ERP, Behavior
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No groups | – | Device: No interventionIDE used for outcome measurement not intervention |
Who may qualify
- Ages
- 90 to 101 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy 8-year-old children
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionIDE used for outcome measurement not intervention | Device | No groups |
Primary outcome
Brain function test
Time frame: 8 year old
Language processing tests
Time frame: 8 year old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Derived from this study: PubMed 25167204Ou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiawei Ou, Ph.D. principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain function test (time frame: 8 year old). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.