Author, as appears in the article.: Picaud, Jean-Charles; Pajek, Barbara; Arciszewska, Malgorzata; Tarczon, Izabela; Escribano, Joaquin; Porcel, Rocio; Adelt, Thomas; Hassink, Elly; Rijnierse, Anneke; Abrahamse-Berkeveld, Marieke; Korczowski, Bartosz; Mazela, Jan; Schlembach, Dietmar; Oudshoorn, Annemarie; Kalach, Nicolas; Pastor Rosado, Jose; Closa, Ricardo; Nermes, Merja; Laitinen, Kirsi;TENUTO Study Grp

Department: Medicina i Cirurgia

URV's Author/s: Escribano Subías, Joaquín

Keywords: Weight Tolerance Standards Safety Regulatory t-cells Primary prevention Prebiotic Partially hydrolyzed formula Mixture Milk Infant growth Galacto-oligosaccharides Fructo-oligosaccharides Age safety prebiotic partially hydrolyzed formula infant growth

Abstract: 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.

Thematic Areas: Zootecnia / recursos pesqueiros Saúde coletiva Química Psicología Planejamento urbano e regional / demografia Nutrition and dietetics Nutrition & dietetics Nutrição Medicina veterinaria Medicina iii Medicina ii Medicina i Interdisciplinar Food science Farmacia Engenharias iv Engenharias ii Enfermagem Educação física Economia Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Ciências agrárias i Ciência de alimentos Biotecnología

licence for use: https://creativecommons.org/licenses/by/3.0/es/

ISSN: 20726643

Author's mail: joaquin.escribano@urv.cat

Author identifier: 0000-0002-5041-459X

Record's date: 2023-02-19

Papper version: info:eu-repo/semantics/publishedVersion

Link to the original source: https://www.mdpi.com/2072-6643/12/7/2072

Licence document URL: http://repositori.urv.cat/ca/proteccio-de-dades/

Papper original source: Nutrients. 12 (7):

APA: Picaud, Jean-Charles; Pajek, Barbara; Arciszewska, Malgorzata; Tarczon, Izabela; Escribano, Joaquin; Porcel, Rocio; Adelt, Thomas; Hassink, Elly; Rijn (2020). 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. Nutrients, 12(7), -. DOI: 10.3390/nu12072072

Article's DOI: 10.3390/nu12072072

Entity: Universitat Rovira i Virgili

Journal publication year: 2020

Publication Type: Journal Publications