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Growth of Infants Fed Formula with Evolving  Nutrition Composition: A Single‐Arm Non‐Inferiority Study

Department of Gastroenterology and Hepatology, Children’s Hospital, CH‐6000 Lucerne, Switzerland
Department of Pediatric Gastroenterology, University Children’s Hospital, CH‐1011 Lausanne, Switzerland
Department of Pediatrics, University Hospital of Geneva, CH‐1205 Geneva, Switzerland
Department of Pediatrics, University Children’s Hospital Basel (UKBB), CH‐4031 Basel, Switzerland
Nestlé Nutrition Research, King of Prussia, PA 19406, USA
Nestlé Research Center, CH‐1000 Lausanne, Switzerland
Nestlé Nutrition Research, CH‐1800 Vevey, Switzerland
Nestlé Product Technology Center, CH‐1800 Vevey, Switzerland
Nestlé Nutrition Medical, Scientific and Regulatory affairs Unit, CH‐1800 Vevey, Switzerland
Nestlé Health Science, CH‐1800 Vevey, Switzerland
Author to whom correspondence should be addressed.
Nutrients 2017, 9(3), 219;
Received: 16 December 2016 / Accepted: 24 February 2017 / Published: 1 March 2017
The nutritional composition of human milk evolves over the course of lactation, to match the changing needs of infants. This single‐arm, non‐inferiority study evaluated growth against the WHO standards in the first year of life, in infants consecutively fed four age‐based formulas with compositions tailored to infants’ nutritional needs during the 1st, 2nd, 3rd–6th, and 7th–12th months of age. Healthy full‐term formula‐fed infants (n = 32) were enrolled at ≤14 days of age and exclusively fed study formulas from enrollment, to the age of four months. Powdered study formulas were provided in single‐serving capsules that were reconstituted using a dedicated automated preparation system, to ensure precise, hygienic preparation. The primary outcome was the weight‐for‐age z‐score (WAZ) at the age of four months (vs. non‐inferiority margin of −0.5 SD). Mean (95% CI) z‐scores for the WAZ (0.12 (−0.15, 0.39)), as well as for the length‐for‐age (0.05 (−0.19, 0.30)), weight‐for‐length (0.16 (−0.16, 0.48)), BMI‐for‐age (0.11 (−0.20, 0.43)), and head circumferencefor‐age (0.41 (0.16, 0.65)) at the age of four months, were non‐inferior. Throughout the study, anthropometric z‐scores tracked closely against the WHO standards (within ±1 SD). In sum, a fourstage, age‐based infant formula system with nutritional compositions tailored to infants’ evolving needs, supports healthy growth consistent with WHO standards, for the first year of life. View Full-Text
Keywords: human milk; evolving nutritional composition; infant formula; protein; staged‐formula  delivery system; WHO growth standard; personalized nutrition human milk; evolving nutritional composition; infant formula; protein; staged‐formula  delivery system; WHO growth standard; personalized nutrition
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Spalinger, J.; Nydegger, A.; Belli, D.; Furlano, R.I.; Yan, J.; Tanguy, J.; Pecquet, S.; Destaillats, F.; Egli, D.; Steenhout, P. Growth of Infants Fed Formula with Evolving  Nutrition Composition: A Single‐Arm Non‐Inferiority Study. Nutrients 2017, 9, 219.

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