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Impact of Infant Feeding on Newborn Metabolomic Profile

NCT01606683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-04

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    collaborator OTHER

  • University of Cagliari

    collaborator OTHER

  • Heinz Italia SpA

    lead INDUSTRY

Principal Investigators

  • Mauro Stronati, Prof. · FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-08-31
Completion
2014-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606683 on ClinicalTrials.gov