Impact of Infant Feeding on Newborn Metabolomic Profile

February 2, 2015 updated by: Heinz Italia SpA
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP 1
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.
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: GROUP 2
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.
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: CONTROL GROUP
Breast milk
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrolment, after 60 and 135 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinz Italia SpA

Collaborators

University of Cagliari
IRCCS Policlinico S. Matteo

Investigators

  • Principal Investigator: Mauro Stronati, Prof., Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLA-LENI-09 - SUBSTUDY 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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