Impact of Infant Feeding on Newborn Metabolomic Profile

Not Applicable

Completed

• Conditions: Breast Feeding of Healthy Full Term Infants; Formula Feeding of Healthy Full Term Infants
• Interventions: Other: Infant formula with GOS, beta-palmitate, acidified milk; Other: Standard infant formula without functional ingredients; Other: No intervention

• Registration Number: NCT01606683
• Lead Sponsor: Heinz Italia SpA

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-28
• Primary Completion: 2013-08
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 1	Infant formula with GOS, beta-palmitate, acidified milk	Infant formula supplemented with with functional ingredients (galacto-oligosaccharides, beta-palmitate, fermented milk). Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae.
GROUP 2	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.
CONTROL GROUP	No intervention	Breast milk

Primary Outcome Measures

Name	Time	Method
Metabolite patterns associated with different dietary regimens	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.

Trial Locations

Locations (1)

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva; 🇮🇹 Pavia, PV, Italy