Arla Foods Ingredients’ Lacprodan IF-3070 infant formula matches breastfed growth trajectories in clinical trial
A six-month randomised controlled trial has confirmed that an infant formula containing Arla Foods Ingredients’ partially hydrolysed whey protein ingredient, Lacprodan® IF-3070, supports healthy growth trajectories comparable to those observed in exclusively breastfed infants, whilst demonstrating a favourable gastrointestinal tolerance profile relative to standard cow’s milk protein formula.
Study design and participant population
The multicentre, triple-blind, randomised non-inferiority trial – conducted across six neonatal care units in China under the name NIHAO (Nutritional Intervention-Hydrolysate for comfort And Optimal growth) – enrolled 251 healthy, full-term singleton infants aged 14 days or under. Participants were randomised 1:1 to receive either a partially hydrolysed formula (pHF) containing approximately 40% Lacprodan IF-3070, or a standard intact cow’s milk protein formula (SF). A propensity score-matched cohort of exclusively breastfed (BF) infants served as a reference group. The study was carried out at Peking University in collaboration with Junlebao Dairy Group, with Professor Yvan Vandenplas of UZ Brussel acting as consultant and co-investigator.
Lacprodan IF-3070 is a partially hydrolysed whey protein ingredient with a degree of hydrolysis of 11–16%, specifically designed to support gastrointestinal comfort in healthy infants. The test formula comprised approximately 40% hydrolysed whey alongside intact whey and casein, maintaining a whey-to-casein ratio of 60:40 in line with regulatory requirements.
Primary outcome: weight gain
The primary endpoint – mean daily weight gain over six months – was 26.0 g/day in the pHF group and 25.3 g/day in the SF group. The adjusted mean difference of 0.64 g/day (95% CI: −1.55, 2.83) confirmed non-inferiority of the pHF against the SF, with the lower confidence interval bound well above the predefined margin of −3 g/day. The breastfed reference group recorded a mean daily weight gain of 26.4 g/day – a difference of just 0.4 g/day compared with the pHF group.
Growth trajectories and WHO z-scores
Linear mixed-effects modelling of WHO child growth standard z-scores revealed that infants in the SF group showed a significantly slower increase in length-for-age z-score (LAZ) over time compared with those in the pHF group (β = −0.17, 95% CI: −0.28 to −0.06, p = 0.003). After six months, SF-fed infants also recorded significantly lower weight-for-age z-scores (WAZ) and head circumference-for-age z-scores (HCZ) relative to the BF group. No significant differences in any WHO z-score were observed between the pHF and BF groups, indicating that growth patterns associated with the test formula more closely approximated those of breastfed infants.
Gastrointestinal tolerance and adverse events
The incidence of gastrointestinal disorders was significantly higher in the SF group (46.9%) than in the BF group (28.3%), with a higher mean number of gastrointestinal events per infant (0.81 vs. 0.39, p = 0.029). No significant differences in gastrointestinal adverse events were recorded between the pHF and BF groups, suggesting a tolerability advantage for the partially hydrolysed formulation. No serious adverse events occurred across any group throughout the study.
Lotte Neergaard Jacobsen, Chief Scientist, Early Life Nutrition, at Arla Foods Ingredients, said: “We invest heavily in research to ensure the safety and high standards of our ingredients, and we’re delighted that the first clinical study on Lacprodan IF-3070 has confirmed that it supports healthy growth.”
Regulatory status and market access
Lacprodan IF-3070 is approved for use in infant formula in both China and the United States, following FDA approval of whey protein hydrolysates in infant formula in 2024. The published study is the first in a planned series of four publications arising from the NIHAO trial.
- For more information, visit: arlafoodsingredients.com
Journal reference:
Shen, Q., Jiang, H., Mao, S., et. al. (2026). An infant formula with partially hydrolyzed whey and intact protein demonstrates adequate growth and safety: A 6-month randomized, triple-blind, controlled trial. Nutrients, 18(5), 770. https://doi.org/10.3390/nu18050770
