NDLI: Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

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Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

Content Provider	Europe PMC
Author	Otten, Lindsey Schelker, Elisabeth Petersen, Hanna Nomayo, Antonia Fleddermann, Manja Arendt, Bianca M. Britzl, Theresa Haberl, Elisabeth M. Jochum, Frank
Editor	Kusuda, Satoshi
Copyright Year	2023
Abstract	We aimed to demonstrate that healthy term infants experience noninferior growth with infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow’s milk protein (control formula, CF). This prospective, randomised, double-blind, parallel-group, controlled, multicentre trial included healthy term infants who were exclusively formula-fed. Infants ≤ 25 days of age received eHF or CF for at least three months up to 120 days of age, with a follow-up until 180 days of age. A reference group included exclusively breastfed infants (BF). Of 318 infants randomised, 297 (148 CF, 149 eHF) completed the study per protocol. Weight gain up to 120 days of age was noninferior (margin −3.0 g/day) in eHF (28.95 (95% CI: 27.21; 30.68) g/day) compared to CF (28.85 (95% CI: 27.10; 30.61) g/day) with a difference in means of 0.09 g/day and a lower limit of the one-sided 97.5% CI of −0.86 g/day (p < 0.0001 for noninferiority testing). Weight gain remained comparable during follow-up. Further anthropometric parameters did not differ between the infant formula groups throughout the study. Growth was comparable in BF. No relevant safety issues were observed. To conclude, eHF meets infant requirements for adequate growth during the first six months of life and can be considered safe and suitable.
Journal	Nutrients
Volume Number	15
PubMed Central reference number	PMC10146495
Issue Number	8
PubMed reference number	37111119
e-ISSN	20726643
DOI	10.3390/nu15081901
Language	English
Publisher	MDPI
Publisher Date	2023-04-14
Access Restriction	Open
Rights License	Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). © 2023 by the authors.
Subject Keyword	extensively hydrolysed whey protein protein hydrolysate infant formula infant nutrition infant weight infant growth breastfed neonatal
Content Type	Text
Resource Type	Article
Subject	Food Science Nutrition and Dietetics

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