Autor segons l'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
Departament: Medicina i Cirurgia
Autor/s de la URV: Closa Monasterolo, Ricardo / Escribano Subías, Joaquín
Paraules clau: 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
Resum: 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.
Àrees temàtiques: 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
Accès a la llicència d'ús: https://creativecommons.org/licenses/by/3.0/es/
ISSN: 20726643
Adreça de correu electrònic de l'autor: joaquin.escribano@urv.cat ricardo.closa@urv.cat
Identificador de l'autor: 0000-0002-5041-459X 0000-0002-9963-4163
Data d'alta del registre: 2024-01-13
Versió de l'article dipositat: info:eu-repo/semantics/publishedVersion
Enllaç font original: https://www.mdpi.com/2072-6643/12/7/2072
Referència a l'article segons font original: Nutrients. 12 (7):
Referència de l'ítem segons les normes 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
URL Document de llicència: https://repositori.urv.cat/ca/proteccio-de-dades/
DOI de l'article: 10.3390/nu12072072
Entitat: Universitat Rovira i Virgili
Any de publicació de la revista: 2020
Tipus de publicació: Journal Publications