Impact of Infant Feeding on Newborn Metabolomic Profile

Formula Feeding of Healthy Full Term Infants Clinical Trial

Official title:

Impact of Infant Feeding on Newborn Metabolomic Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606683
• Other study ID #: PLA-LENI-09 - SUBSTUDY 1
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: February 2, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Heinz Italia SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Feeding of Healthy Full Term Infants
• Formula Feeding of Healthy Full Term Infants

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva	Pavia	PV

Sponsors (3)

Lead Sponsor	Collaborator
Heinz Italia SpA	IRCCS Policlinico S. Matteo, University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (19)

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. Review. — View Citation

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;2:725-32. — View Citation

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;3:1005-12. — View Citation

Bell JD, Sadler PJ, Morris VC, Levander OA. Effect of aging and diet on proton NMR spectra of rat urine. Magn Reson Med. 1991 Feb;17(2):414-22. — View Citation

Bertram HC, Hoppe C, Petersen BO, Duus JØ, Mølgaard C, Michaelsen KF. An NMR-based metabonomic investigation on effects of milk and meat protein diets given to 8-year-old boys. Br J Nutr. 2007 Apr;97(4):758-63. — View Citation

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. — View Citation

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.

Fanos V, Barberini L, Antonucci R, Atzori L. Metabolomics in neonatology and pediatrics. Clin Biochem. 2011 May;44(7):452-4. doi: 10.1016/j.clinbiochem.2011.03.006. — View Citation

Gibney MJ, Walsh M, Brennan L, Roche HM, German B, van Ommen B. Metabolomics in human nutrition: opportunities and challenges. Am J Clin Nutr. 2005 Sep;82(3):497-503. Review. — View Citation

Goodacre R, Vaidyanathan S, Dunn WB, Harrigan GG, Kell DB. Metabolomics by numbers: acquiring and understanding global metabolite data. Trends Biotechnol. 2004 May;22(5):245-52. Review. — View Citation

Goodacre R. Metabolomics of a superorganism. J Nutr. 2007 Jan;137(1 Suppl):259S-266S. Review. — View Citation

Janecková H, Hron K, Wojtowicz P, Hlídková E, Barešová A, Friedecký D, Zídková L, Hornik P, Behúlová D, Procházková D, Vinohradská H, Pešková K, Bruheim P, Smolka V, Stastná 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. — View Citation

Nicholson JK, Holmes E, Lindon JC, Wilson ID. The challenges of modeling mammalian biocomplexity. Nat Biotechnol. 2004 Oct;22(10):1268-74. Review. — View Citation

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. Review. — View Citation

Phipps AN, Stewart J, Wright B, Wilson ID. Effect of diet on the urinary excretion of hippuric acid and other dietary-derived aromatics in rat. A complex interaction between diet, gut microflora and substrate specificity. Xenobiotica. 1998 May;28(5):527-37. — View Citation

Ryan D, Robards K. Metabolomics: The greatest omics of them all? Anal Chem. 2006 Dec 1;78(23):7954-8. — View Citation

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. Epub 2009 Jun 12. — View Citation

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. — View Citation

Zhang X, Yap Y, Wei D, Chen G, Chen F. Novel omics technologies in nutrition research. Biotechnol Adv. 2008 Mar-Apr;26(2):169-76. doi: 10.1016/j.biotechadv.2007.11.002. Epub 2007 Nov 19. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No