Impact of Infant Feeding on Newborn Metabolomic Profile
NCT ID: NCT01606683
Last Updated: 2015-02-04
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-04-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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.
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
No intervention
Interventions
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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.
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.
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Days
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
University of Cagliari
OTHER
Heinz Italia SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Mauro Stronati, Prof.
Role: PRINCIPAL_INVESTIGATOR
FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
Locations
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Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, Italy
Countries
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References
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Fanos V, Barberini L, Antonucci R, Atzori L. Metabolomics in neonatology and pediatrics. Clin Biochem. 2011 May;44(7):452-454. doi: 10.1016/j.clinbiochem.2011.03.006. No abstract available.
Atzori L, Antonucci R, Barberini L, Griffin JL, Fanos V. Metabolomics: a new tool for the neonatologist. J Matern Fetal Neonatal Med. 2009;22 Suppl 3:50-3. doi: 10.1080/14767050903181500.
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Other Identifiers
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PLA-LENI-09 - SUBSTUDY 1
Identifier Type: -
Identifier Source: org_study_id
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