Impact of Infant Feeding on Newborn Metabolomic Profile

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fondazione IRCCS Policlinico San Matteo - Struttura Complessa di Neonatologia, Patologia Neonatale e Terapia Intensiva (Prof. Mauro Stronati)
University of Cagliari (Prof. Vassilios Fanos)
Information provided by (Responsible Party):
Heinz Italia SpA
ClinicalTrials.gov Identifier:
NCT01606683
First received: May 24, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Infant Feeding on Newborn Metabolomic Profile

Resource links provided by NLM:


Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:
  • Metabolite patterns associated with different dietary regimens [ Time Frame: At enrolment, after 60 and 135 days of life ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
CONTROL GROUP
Breast milk
Other: No intervention
-

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.

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606683

Locations
Italy
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, Italy, 27100
Sponsors and Collaborators
Heinz Italia SpA
Fondazione IRCCS Policlinico San Matteo - Struttura Complessa di Neonatologia, Patologia Neonatale e Terapia Intensiva (Prof. Mauro Stronati)
University of Cagliari (Prof. Vassilios Fanos)
Investigators
Principal Investigator: Mauro Stronati, Prof. FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
  More Information

Publications:
Ciccarelli S, Atzori L, Noto A, Barberini L, Fanos V, Caramia G, Agostino R. Spontaneous vs cesarean delivery: a metabolomic point of view. J Matern Fetal Neonatal Med 24(S(2):1-2, 2011.

Responsible Party: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT01606683     History of Changes
Other Study ID Numbers: PLA-LENI-09 - SUBSTUDY 1
Study First Received: May 24, 2012
Last Updated: August 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:
Acidified milk
Beta-palmitate
Bifidobacteria
Breastfeeding
Infant formula
Galacto-oligosaccharides
Growth
Infants
Metabolomics
Prebiotics

ClinicalTrials.gov processed this record on September 22, 2014