The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional ingredients and a group of breast-fed infants.
Metabolomics is of particular interest in the field of nutrition, since nutrients interact with a number of targets, metabolic pathways and functions. A suitable biofluid to study nutrient intake is urine, which is the most commonly used biological sample for metabolomic analysis and can be collected with simple and non-invasive methods. Up to now, no studies have investigated healthy term infants metabolome and its modulation according to different dietary regimens such as formula-feeding or breastfeeding. The aim of this study is to evaluate, with untargeted modalities, the urine metabolomic profile of a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional ingredients and a group of breast-fed infants. Formula-fed infants participate to PLA-LENI-09 study (NCT01197365). We have included also a control group of breast-fed infants, as, from a scientific point of view, they represent the "gold standard" and no data are available on their metabolomic profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae.
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, Italy
Metabolite patterns associated with different dietary regimens
Urine will be analysed using 1H-NMR. Data will be analyzed through the use of software products to enable the discovery of hundreds of different metabolites involved in multiple pathways and connected with different conditions. The metabolites on which the univariate analysis will be performed are the most important revealed by the multivariate analysis (VIP variables) and Student's statistical test will be performed.
Time frame: At enrolment, after 60 and 135 days of life
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