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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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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. |
format | Online Article Text |
id | pubmed-7400250 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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