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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

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 c...

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Autores principales: Picaud, Jean-Charles, Pajek, Barbara, Arciszewska, Malgorzata, Tarczón, Izabela, Escribano, Joaquin, Porcel, Rocio, Adelt, Thomas, Hassink, Elly, Rijnierse, Anneke, Abrahamse-Berkeveld, Marieke, Korczowski, Bartosz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400250/
https://www.ncbi.nlm.nih.gov/pubmed/32668666
http://dx.doi.org/10.3390/nu12072072
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author Picaud, Jean-Charles
Pajek, Barbara
Arciszewska, Malgorzata
Tarczón, Izabela
Escribano, Joaquin
Porcel, Rocio
Adelt, Thomas
Hassink, Elly
Rijnierse, Anneke
Abrahamse-Berkeveld, Marieke
Korczowski, Bartosz
author_facet Picaud, Jean-Charles
Pajek, Barbara
Arciszewska, Malgorzata
Tarczón, Izabela
Escribano, Joaquin
Porcel, Rocio
Adelt, Thomas
Hassink, Elly
Rijnierse, Anneke
Abrahamse-Berkeveld, Marieke
Korczowski, Bartosz
author_sort Picaud, Jean-Charles
collection PubMed
description 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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spelling pubmed-74002502020-08-23 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 Picaud, Jean-Charles Pajek, Barbara Arciszewska, Malgorzata Tarczón, Izabela Escribano, Joaquin Porcel, Rocio Adelt, Thomas Hassink, Elly Rijnierse, Anneke Abrahamse-Berkeveld, Marieke Korczowski, Bartosz Nutrients Article 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. MDPI 2020-07-13 /pmc/articles/PMC7400250/ /pubmed/32668666 http://dx.doi.org/10.3390/nu12072072 Text en © 2020 by the authors. 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 (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Picaud, Jean-Charles
Pajek, Barbara
Arciszewska, Malgorzata
Tarczón, Izabela
Escribano, Joaquin
Porcel, Rocio
Adelt, Thomas
Hassink, Elly
Rijnierse, Anneke
Abrahamse-Berkeveld, Marieke
Korczowski, Bartosz
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400250/
https://www.ncbi.nlm.nih.gov/pubmed/32668666
http://dx.doi.org/10.3390/nu12072072
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