NCT01606683

Impact of Infant Feeding on Newborn Metabolomic Profile

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Heinz Italia SpA · Industry
• Sex: All
• Age: 21 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Formula Feeding of Healthy Full Term Infants
• Breast Feeding of Healthy Full Term Infants

Interventions

Type	Name	Description
OTHER	Infant formula with GOS, beta-palmitate, acidified milk	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.
OTHER	Standard infant formula without functional ingredients	Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.
OTHER	No intervention

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-08-01
• Completion: 2014-12-01
• First posted: 2012-05-28
• Last updated: 2015-02-04

Locations

1 site across 1 country: Italy