Impact of Infant Feeding on Newborn Metabolomic Profile

NCT01606683 | Completed

• 1 other identifier: PLA-LENI-09 - SUBSTUDY 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Metabolite patterns associated with different dietary regimens

  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

Study Arms (3)

GROUP 1

EXPERIMENTAL

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

GROUP 2

OTHER

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

CONTROL GROUP

OTHER

Breast milk

Other: No intervention

Interventions

Infant formula with GOS, beta-palmitate, acidified milk OTHER

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 1

Standard infant formula without functional ingredients OTHER

Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.

GROUP 2

No intervention OTHER

CONTROL GROUP

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinz Italia SpA: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• University of Cagliari: collaborator

Study Sites (1)

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Pavia, PV, 27100, Italy

Location

Related Publications (19)

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• 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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• Nicholson JK, Wilson ID. Opinion: understanding 'global' systems biology: metabonomics and the continuum of metabolism. Nat Rev Drug Discov. 2003 Aug;2(8):668-76. doi: 10.1038/nrd1157. No abstract available.

  PMID: 12904817 BACKGROUND

• Nicholson JK, Holmes E, Lindon JC, Wilson ID. The challenges of modeling mammalian biocomplexity. Nat Biotechnol. 2004 Oct;22(10):1268-74. doi: 10.1038/nbt1015.

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• Carraro S, Giordano G, Reniero F, Perilongo G, Baraldi E. Metabolomics: a new frontier for research in pediatrics. J Pediatr. 2009 May;154(5):638-44. doi: 10.1016/j.jpeds.2009.01.014. No abstract available.

  PMID: 19364557 BACKGROUND

• Janeckova H, Hron K, Wojtowicz P, Hlidkova E, Baresova A, Friedecky D, Zidkova L, Hornik P, Behulova D, Prochazkova D, Vinohradska H, Peskova K, Bruheim P, Smolka V, Stastna S, Adam T. Targeted metabolomic analysis of plasma samples for the diagnosis of inherited metabolic disorders. J Chromatogr A. 2012 Feb 24;1226:11-7. doi: 10.1016/j.chroma.2011.09.074. Epub 2011 Oct 4.

  PMID: 22018716 BACKGROUND

• Atzori L, Antonucci R, Barberini L, Locci E, Cesare Marincola F, Scano P, Cortesi P, Agostiniani R, Weljie A, Lai A, Fanos V. 1H NMR-based metabolic profiling of urine from children with nephrouropathies. Front Biosci (Elite Ed). 2010 Jan 1;2(2):725-32. doi: 10.2741/e132.

  PMID: 20036916 BACKGROUND

• Atzori L, Antonucci R, Barberini L, Locci E, Marincola FC, Scano P, Cortesi P, Agostiniani R, Defraia R, Weljie A, Gazzolo D, Lai A, Fanos V. 1H NMR-based metabolomic analysis of urine from preterm and term neonates. Front Biosci (Elite Ed). 2011 Jun 1;3(3):1005-12. doi: 10.2741/e306.

  PMID: 21622109 BACKGROUND

• 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.

  BACKGROUND

• Scalbert A, Brennan L, Fiehn O, Hankemeier T, Kristal BS, van Ommen B, Pujos-Guillot E, Verheij E, Wishart D, Wopereis S. Mass-spectrometry-based metabolomics: limitations and recommendations for future progress with particular focus on nutrition research. Metabolomics. 2009 Dec;5(4):435-458. doi: 10.1007/s11306-009-0168-0. Epub 2009 Jun 12.

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• Walsh MC, Brennan L, Malthouse JP, Roche HM, Gibney MJ. Effect of acute dietary standardization on the urinary, plasma, and salivary metabolomic profiles of healthy humans. Am J Clin Nutr. 2006 Sep;84(3):531-9. doi: 10.1093/ajcn/84.3.531.

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  PMID: 17349089 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Mauro Stronati, Prof.

  FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IT (1)