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Breast vs. formula: which diet shapes baby brains best?

NCT ID NCT00616395

Knowledge-focused Sponsor: Arkansas Children's Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study followed 600 healthy infants from 2 months to 6 years old to see how being fed mostly breast milk, milk-based formula, or soy-based formula affects their growth, body composition, and brain function. Researchers measured physical development and neurobehavioral milestones. The goal is to better understand how early diet influences long-term health and development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help parents and doctors understand which infant diet supports the best growth and brain development.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

600 people

The number who actually took part.

Started

Sep 2002

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy infants

Ages

1 month to 3 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy Infants * Birth weight = 6 to 9 lbs * Mostly fed breast milk, milk-based formula, soy-based formula * Mother over 18 years of age Exclusion Criteria: * Unhealthy pregnancy * Illness during pregnancy or for the child that could interfere with the study parameters

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Arkansas Children's Nutrition Center

    Little Rock, Arkansas, 72202, United States

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