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Completed

NCT Number: NCT01606683

Impact of Infant Feeding on Newborn Metabolomic Profile

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.

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Key information

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Pavia, PV, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants being exclusively either breastfed or formula-fed by the 21st day of life
  • Infants of both sexes born with natural or caesarian delivery
  • Gestational age between 37 and 42 completed weeks
  • Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
  • Single birth
  • Caucasian parents

Exclusion criteria

  • Infants with genetic and/or congenital diseases
  • Infants receiving antibiotic therapy
  • Infants with neonatal diseases requiring hospitalisation for longer than 7 days
  • Infants at risk for atopy and/or having familial history for atopy
  • Mothers with metabolic or chronic diseases
  • Infant selected for another clinical study
  • Parents refusing to sign a written informed consent

Treatment and study plan

Infant formula with GOS, beta-palmitate, acidified milk

Other

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 without functional ingredients

Other

Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.

No intervention

Other

Primary outcomes

  1. Metabolite patterns associated with different dietary regimens

    Time frame: At enrolment, after 60 and 135 days of life

    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.

Sponsors and collaborators

Lead sponsor

Heinz Italia SpA

Industry

Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • University of Cagliari

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 28, 2012
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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