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Baby food study aims to unlock secrets of infant growth and gut bacteria

NCT ID NCT05012930

Knowledge-focused Sponsor: University of Colorado, Denver 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study follows 267 healthy, full-term infants from about 5 to 12 months old to see how different types of baby foods—meat, dairy, plant-based, or home foods—affect their growth and gut bacteria. Researchers will measure weight, length, body composition, and gut microbiome changes. The goal is to provide evidence for future infant feeding recommendations.

What this could mean

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

Active substance
Baby foods (meat, dairy, plant-based, or home foods)
What this could lead to
If successful, this could help shape better dietary guidelines for infant feeding to support healthy growth and gut development.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change health outcomes. Results may not apply to all infants, especially those born preterm or with health issues.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

267 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2026

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.

Ages

4 to 60 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: * Full term; * Generally healthy without conditions that would affect protein metabolism or growth * No previous complementary food exposure * Vaginal delivery * No prior exposure of antibiotics during delivery or after birth * Able to consume study foods * Single birth. Exclusion Criteria: * Pre-term infants. * Having conditions that would affect normal growth * Had complementary foods prior to the start of the study * Not willing to consume the complementary foods provided * Antibiotics exposure during delivery or from birth to 5 months of life * Multiple births

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As listed by the trial registrant

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

Gut microbiome Linear growth

Contacts and locations

Locations

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

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