Peer-reviewed article
An Infant Formula with Partially Hydrolyzed Whey and Intact Protein Demonstrates Adequate Growth and Safety: A 6-Month Randomized, Triple-Blind, Controlled Trial.
Qianqian Shen, Hua Jiang, Shuai Mao, Sha Luo, Yanjie Hao et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested whether infant formula containing partially hydrolyzed whey protein supports healthy growth in babies up to 6 months old. Researchers compared three groups: babies fed the new formula, babies fed standard formula, and breastfed babies. The new formula performed nearly as well as standard formula and similarly to breastfed babies in terms of weight gain and overall growth, with fewer digestive problems than standard formula.
Key points
- Daily weight gain was 26.0 g/day for the partially hydrolyzed formula group, 25.3 g/day for standard formula, and 26.4 g/day for breastfed infants
- Growth parameters including weight-for-age and length-for-age z-scores remained within normal ranges for all groups
- The partially hydrolyzed formula group had similar length-for-age growth to breastfed infants, while standard formula showed slower length increase
- Gastrointestinal disorders were more common in the standard formula group than in both the partially hydrolyzed formula and breastfed groups
- The formula was well tolerated with no safety concerns identified over the 6-month period
Limitations
The study does not identify the specific country or countries where the trial was conducted, making it unclear whether findings apply to specific African contexts. The study only evaluates safety and growth outcomes over 6 months and does not assess longer-term developmental effects or comparative cost-effectiveness of different formulas.
Abstract
BACKGROUND/OBJECTIVES: Evidence suggests that partially hydrolyzed whey protein promotes appropriate infant growth; however, research on its long-term effects, especially in Asia, remains limited. This study set out to evaluate the effects of an infant formula containing partially hydrolyzed whey and intact protein on infant growth and development. METHODS: This multicenter, triple-blind, randomized non-inferiority trial enrolled healthy full-term infants (≤14 days old). Participants were randomized (1:1) to receive pHF (n = 78) or SF (n = 70) until 6 months of age, with propensity score-matched exclusively breastfed (BF) infants (n = 70) serving as the reference. The primary outcome was daily weight gain. Linear mixed models assessed the association between feeding type and WHO z-scores over time. RESULTS: Over 6 months, the adjusted mean (SE) daily weight gain (g) was 26.4 (1.27) g/day in BF, 26.0 (1.19) g/day in pHF, and 25.3 (1.27) g/day in the SF group. The adjusted mean difference between pHF and SF was 0.64 g/day (95%CI: -1.55, 2.83), confirming non-inferiority. Growth parameters were comparable between pHF and SF, with WHO z-scores remaining within ±1 SD of reference standards. Compared with pHF, SF was associated with a slower increase in length-for-age z score (LAZ). While there was no difference between the pHF and BF groups, WAZ increased significantly less in SF vs. BF [-0.34 (95%CI: -0.58, -0.10), p = 0.003]. Gastrointestinal disorders occurred more frequently in the SF group than in the BF group, with no significant difference between the pHF and BF groups. CONCLUSIONS: An infant formula containing partially hydrolyzed whey and intact protein supported adequate growth and was well tolerated during the first six months of life, with growth trajectories comparable to those of breastfed infants.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Infant formula containing partially hydrolyzed whey and intact protein
- Population
- Healthy full-term infants ≤14 days old (n=78 in intervention group); comparison groups included 70 on standard formula and 70 breastfed infants
Key finding
Daily weight gain: partially hydrolyzed formula 26.0 g/day vs standard formula 25.3 g/day (mean difference 0.64 g/day, 95%CI: -1.55, 2.83), confirming non-inferiority