Clinical trial NCT01606683: Impact of Infant Feeding on Newborn Metabolomic Profile
Official title: Impact of Infant Feeding on Newborn Metabolomic Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Formula Feeding of Healthy Full Term Infants
Breast Feeding of Healthy Full Term Infants
Keywords: Acidified milk
Beta-palmitate
Bifidobacteria
Breastfeeding
Infant formula
Galacto-oligosaccharides
Growth
Infants
Metabolomics
Prebiotics
Lead sponsor: Heinz Italia SpA
Sponsor class: INDUSTRY
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: University of Cagliari
First posted: 2012-05-28
Enrollment: 30
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Metabolite patterns associated with different dietary regimens
timeFrame: At enrolment, after 60 and 135 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
state: PV
Study officials:
affiliation: FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
name: Mauro Stronati, Prof.
role: PRINCIPAL_INVESTIGATOR
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