A1 Refereed original research article in a scientific journal
An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial
Authors: Picaud JC, Pajek B, Arciszewska M, Tarczon I, Escribano J, Porcel R, Adelt T, Hassink E, Rijnierse A, Abrahamse-Berkeveld M, Korczowski B; and on behalf of the TENUTO Study Group
Publisher: MDPI
Publication year: 2020
Journal: Nutrients
Journal name in source: NUTRIENTS
Journal acronym: NUTRIENTS
Article number: ARTN 2072
Volume: 12
Issue: 7
Number of pages: 16
DOI: https://doi.org/10.3390/nu12072072
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/49140267
The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow's milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n= 134) or IPF (n= 134) from <= 14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/-3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means -1.2 g/d; 90% CI (-2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.
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