Late-breaking findings presented July 28 at NUTRITION 2026 showed infant formula met Food Drug Administration-required growth and safety measures
- The a2 Milk Company presented results from Growth Monitoring Study as a late-breaking oral presentation at NUTRITION 2026.
- The study evaluated infant milk formula made from cow’s milk free from A1-type beta-casein (A1PF) and found it supported normal growth and safety through to 16 weeks of age, meeting predefined U.S. Food and Drug Administration criteria and remaining within World Health Organization-defined healthy growth ranges.
- Exploratory analyses found greater average gains in length and weight among infants fed A1PF formula compared to conventional formula.
WASHINGTON, July 28, 2026 (GLOBE NEWSWIRE) -- The a2 Milk Company today announced results from a randomized, double-blind, controlled study evaluating an infant milk formula made with cow’s milk free of A1-type beta-casein protein, referred to as A1PF formula, compared to an infant milk formula made with conventional cow’s milk.
The findings were presented as a late-breaking oral presentation at NUTRITION 2026, the American Society for Nutrition’s annual meeting.
The Growth Monitoring Study was funded by The a2 Milk Company and conducted in line with U.S. Food and Drug Administration (FDA) requirements for new formula registration. Results found that A1PF formula supported normal growth and safety throughout the 16-week period in healthy term infants.
How A1- and A2-type beta-casein differ
Beta-casein is one of the main proteins found in cow’s milk. It occurs as a number of natural variants, which can be classified as either A1- or A2-type beta-casein. Most conventional cow’s milk contains a combination of both protein types.
A1- and A2-type beta-casein differ by a single amino acid, which affects how the proteins are broken down during digestion. A1PF formula is made with milk containing only A2-type beta-casein and no A1-type beta-casein.
A1PF formula met predefined growth criteria
The study’s primary objective was to determine whether A1PF formula performed comparably to conventional formula in supporting weight gain over the 16-week study period.
Between baseline and week 16, infants fed A1PF formula had a mean daily weight gain of 31.94 grams, compared with 30.15 grams among infants fed conventional formula. The difference of 1.79 grams per day exceeded the study’s predefined non-inferiority threshold of minus 3 grams per day. Growth was evaluated in the context of World Health Organization (WHO) growth standards and infants fed A1PF formula remained within the WHO-defined healthy ranges throughout the study. There were also no significant differences between groups for adverse events experiences.
Together, these results demonstrated that A1PF formula supported appropriate growth and safety within FDA guidelines.
Further analyses identified additional growth findings
Post hoc analyses were conducted to further explore growth outcomes. These analyses were not part of the study’s primary objective and should be considered exploratory.
Throughout the 16-week study period, infants fed A1PF formula:
- Achieved significantly greater average weight gain. A1PF formula-fed infants gained 3,577.78 grams compared with 3,376.50 among infants fed conventional formula, which represented an approximately 6% greater weight gain.
- Demonstrated significantly greater length gain. A1PF formula-fed infants gained 12.88 cm compared with 12.08 for infants fed conventional formula, which represents an approximately 6.6% greater length gain.
- Had significantly higher weight-for-age and length-for-age z-scores at week 16, which compare an infant’s growth with WHO age-based reference standards.
“The study found that infants fed A1PF formula experienced appropriate growth and met the predefined criteria, meaning the formula achieved its central objective” said Andrew Clarke, PhD, Chief Scientific Advisor at The a2 Milk Company. “The additional growth findings are encouraging and provide an important foundation for further research.”
A1PF-fed infants demonstrated greater efficiency in converting dietary protein into growth
Additional analyses found approximately 11% higher protein-to-growth ratios for weight among infants fed A1PF formula compared with infants fed conventional formula. These exploratory findings suggest that A1PF formula may support more favorable protein conversion efficiency.
About the Growth Monitoring Study
The FDA requires new formulas be tested under clinical study conditions to ensure new formulas support normal physical growth, such that they are non-inferior to commercially available formulas with regards to safety, weight gain and normal physical growth.
In a randomized, controlled, double-blind clinical trial conducted in the United States, healthy full-term infants younger than 14 days of age were randomized to receive either A1PF or a conventional formula for 16 weeks.
Growth and safety outcomes were assessed at baseline and throughout the study. The primary endpoint was mean daily weight gain from baseline through week 16. Additional assessments included length, head circumference, age-standardized growth measures, formula intake and adverse events.
About The a2 Milk Company
The a2 Milk Company is a dairy nutrition company that develops products made with milk containing only the A2-type beta-casein protein. For more than 25 years, the company has worked alongside scientists around the world to advance understanding of beta-casein protein science.
The company has products and trading activities across New Zealand, Australia, Greater China, North America and selected emerging markets. Its infant nutrition products are available in key international markets, including China, Australia and Vietnam.
For more information, visit The a2 Milk Company website.
Contact
Katie Pawelczyk, MS, RD
Kpawelczyk@foodminds.com
