Clinical Trial

A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.

Study acronym: GAIA
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product, compared to subjects receiving the Control Product. Also, other anthropometric parameters will be investigated up to 52 weeks. A Breastfed reference group, exclusively breastfed for at least 16 weeks, will also be included.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-21; most recent amendment 2026-03-18.
Status change: Recruiting → Enrolling by Invitation 2026-03-18
Status change: Not Yet Recruiting → Recruiting 2025-01-07
Trial Details
NCT Number NCT06475521
Lead Sponsor Nutricia Research
Conditions Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Enrollment 579 participants
Start Date 2024-07-17
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-23