An Infant Formula with Partially Hydrolyzed Whey and Intact Protein Demonstrates Adequate Growth and Safety: A...

Area of Science:

• Pediatric Nutrition
• Infant Growth and Development
• Protein Hydrolysis

Background:

• Partially hydrolyzed whey protein (pHF) is suggested to promote infant growth, but long-term data, especially in Asian populations, is scarce.
• Limited research exists on the effects of infant formulas containing both partially hydrolyzed whey and intact protein.

Purpose of the Study:

• To evaluate the impact of an infant formula with partially hydrolyzed whey and intact protein on infant growth and development.
• To compare the efficacy and safety of this formula against standard formula and breast milk.

Main Methods:

• A multicenter, triple-blind, randomized non-inferiority trial involving healthy full-term infants (≤14 days old).
• Infants were randomized to receive partially hydrolyzed formula (pHF) or standard formula (SF) until 6 months.
• Propensity score-matched exclusively breastfed (BF) infants served as a reference group.

Main Results:

• Daily weight gain was comparable across BF (26.4 g/day), pHF (26.0 g/day), and SF (25.3 g/day) groups; pHF was non-inferior to SF.
• WHO z-scores remained within ±1 SD for all groups. SF showed slower length-for-age z-score (LAZ) increase compared to pHF.
• Standard formula (SF) was associated with significantly lower weight-for-age z-score (WAZ) increase compared to breastfed (BF) infants and more gastrointestinal disorders.

Conclusions:

• Infant formula with partially hydrolyzed whey and intact protein supports adequate growth in the first six months.
• Growth trajectories were comparable to breastfed infants, and the formula was well-tolerated.
• Partially hydrolyzed whey protein formula offers a viable alternative for infant nutrition.