Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Non-Inferiority Trial

ABSTRACT Objective: A high protein content of non-hydrolyzed infant formula exceeding metabolic requirements can induce rapid weight gain and obesity. Hydrolyzed formula with too low protein (LP) content may result in inadequate growth. The aim of this study was to investigate non-inferiority of partial and extensively hydrolyzed formulas (pHF, eHF) with lower hydrolyzed protein content than conventionally, regularly used formulas, with or without synbiotics for normal growth of healthy term infants. Patients and Methods: In an European multi-centre, parallel, prospective, controlled, double-blind trial, 402 formula-fed infants were randomly assigned to four groups: LP-formulas (1.9 g protein/100 kcal) as pHF (i) with or (ii) without synbiotics, (iii) LP-eHF-formula with synbiotics, or (iv) regular protein eHF (2.3 g protein/100 kcal). 101 breastfed infants served as observational reference group. As primary endpoint, non-inferiority of daily weight gain during the first 4 months of life was investigated comparing the LP-group (i) to a regular protein eHF group (iv). Results: A comparison of daily weight gain in infants receiving LPpHF (2.15 g/d (CI [−0.18,inf.[) with infants receiving regular protein eHF showed non-inferior weight gain (- 3.5 g/d margin) (PP population). Non-inferiority was also confirmed for the other tested LP-formulas. Likewise, analysis of metabolic parameters and plasma amino acid concentrations demonstrated a safe and balanced nutritional composition. Energetic efficiency for growth (weight) was slightly higher in LPeHF+synbiotics compared to LPpHF+synbiotics. Conclusion: All tested hydrolyzed LP-formulas allowed normal weight gain without being inferior to regular protein eHF in the first 4 months of life. This trial was registered at clinicaltrials.gov, NCT01143233. Address correspondence and reprint requests to Kirsten Beyer, MD, Department of Pediatric Pneumology and Immunology, Charité -Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany (e-mail: kirsten.beyer@charite.de). Received 6 February, 2017 Accepted 15 November, 2017 http://ift.tt/1pydFNc Identifier: NCT01143233. Funding: This study was funded by HiPP GmbH & Co. Vertrieb KG, Pfaffenhofen, Germany. Relevant conflicts of interests: BA received a travel reimbursement and honorarium from Allergopharma for active participation in a scientific seminar. NH has received speaker's honoraria from Nestle, Milupa, Hipp, Novolac and Baxter, is running studies for Nestle, Hipp and Winicker Norimed and is currently receiving a grant (No: 15378) from the Austrian National Bank "Jubilee Fund". EH received a travel reimbursement and honorarium from Nutricia and Milupa for his active participation in scientific seminars. Analyses of energetic efficacy of infant formulae by MF were performed within her research activity at the Dr. von Hauner Children's Hospital Munich. MF is now an employee of HiPP GmbH & Co. Vertrieb KG. AK has received honoraria from HiPP GmbH & Co. Vertrieb KG. BK is a member of the National Breastfeeding Committee and declares bias towards breastfeeding. The Ludwig-Maximilians-University (LMU) of Munich Medical Centre and its employees BK and CH had scientific and educational collaboration with manufacturers of nutritional products for infants and children, primarily as part of research collaboration funded by the European Commission, the European Research Council and also with German government funding. The work performed at LMU and reported in this manuscript has been financially supported in part by Hipp. BK does not report a conflict of interest which would represent "a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest", as defined by the US Institute of Medicine. UW received Speaker's fees: ALK, Allergopharma, Stallergenes, Nutricia, Nestle, FAES Pharma; Consultation fees: ALK, Allergopharma, Stallergenes, Novartis, Danone, Hipp, MEDA, Biomay KB has no direct conflict of interest. However, she reports grants and personal fees outside the submitted work from the European Union, German Research Foundation, Danone Research, Nestle, ThermoFisher Scientific, DST Diagnostic, Hycor, DBV, Aimmune, Meda Pharma, ALK, Bausch & Lomb, Novartis, Unilever, Allergopharma, HAL, and MedUpdate. Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). © 2017 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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