Articles producció científica> Medicina i Cirurgia

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

  • Identification data

    Identifier: imarina:7340231
    Authors:
    Picaud, Jean-CharlesPajek, BarbaraArciszewska, MalgorzataTarczon, IzabelaEscribano, JoaquinPorcel, RocioAdelt, ThomasHassink, EllyRijnierse, AnnekeAbrahamse-Berkeveld, MariekeKorczowski, BartoszMazela, JanSchlembach, DietmarOudshoorn, AnnemarieKalach, NicolasPastor Rosado, JoseClosa, RicardoNermes, MerjaLaitinen, KirsiTENUTO Study Grp
    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.
  • Others:

    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: Closa Monasterolo, Ricardo / 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 ricardo.closa@urv.cat
    Author identifier: 0000-0002-5041-459X 0000-0002-9963-4163
    Record's date: 2024-01-13
    Papper version: info:eu-repo/semantics/publishedVersion
    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
    Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
    Entity: Universitat Rovira i Virgili
    Journal publication year: 2020
    Publication Type: Journal Publications
  • Keywords:

    Food Science,Nutrition & Dietetics,Nutrition and Dietetics
    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
    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
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