Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants.

Jacques Rigo,Bart Van Overmeire,Marieke Abrahamse-Berkeveld,Stefanie Schoen,Wivinne Marion,Philippe Alliet,Marc Verghote

doi:10.3390/nu11071654

Abstract

The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was −1.12 g/day (90% CI: [−2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of −2.52 g/day (90% CI: [−4.23; −0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.

Highlights

Human milk represents the “gold standard” in infants’ nutrition due to its important nutritional and functional properties [1]
The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants
The evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants

Summary

Introduction

Human milk represents the “gold standard” in infants’ nutrition due to its important nutritional and functional properties [1]. It has been recommended that infants with a family history of allergy who are not (exclusively) breastfed are provided with a partially (pHF) or extensively hydrolysed formula (eHF) with confirmed reduced allergenicity [6]. In the 1990s, it was shown that the growth rate and protein efficiency could be impaired in infants fed various pHFs in comparison with infants fed either with human milk or with infant formula containing intact protein [11,12]. In 2003, to compensate for these imbalances, the European Scientific Committee of Food report [2] fixed the minimal protein content for pHF at 2.25 g/100 kcal; a value higher than the recommended 1.8 g/100 kcal for infant formula containing intact protein

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Methods

Conclusion