Formula Feeding of Healthy Full Term InfantsNCT01606683
Impact of Infant Feeding on Newborn Metabolomic Profile
A study testing Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients in people with Formula Feeding of Healthy Full Term Infants and Breast Feeding of Healthy Full Term Infants, run by Heinz Italia SpA at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
- What is being tested?
- Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, 27100
About this study
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.
Read the 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.
- Being tested
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients, No intervention
- Keywords
- Acidified milk, Beta-palmitate, Bifidobacteria, Breastfeeding, Infant formula, Galacto-oligosaccharides, Growth, Infants, Metabolomics, Prebiotics
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula with GOS, beta-palmitate, acidified milkOther
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 ingredientsOther
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard infant formula without functional ingredients |
| CONTROL GROUP | Other | Breast milk Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrolment, after 60 and 135 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Formula Feeding of Healthy Full Term InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinz Italia SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, University of Cagliari
- Responsible party
- Sponsor
- Investigators
- Mauro Stronati, Prof., Principal investigator, FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606683
- Sponsor's protocol ID
- PLA-LENI-09 - SUBSTUDY 1
- Status last verified
- Feb 2015
- First submitted
- 24 May 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.tibtech.2004.03.007. No abstract available.
PubMed 15109811Ryan D, Robards K. Metabolomics: The greatest omics of them all? Anal Chem. 2006 Dec 1;78(23):7954-8. doi: 10.1021/ac0614341. No abstract available.
PubMed 17134127Fanos 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.
PubMed 22036322Atzori 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.
PubMed 19701858Goodacre R. Metabolomics of a superorganism. J Nutr. 2007 Jan;137(1 Suppl):259S-266S. doi: 10.1093/jn/137.1.259S.
PubMed 17182837Nicholson 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.
PubMed 12904817Nicholson 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.
PubMed 15470467Carraro 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.
PubMed 19364557Janeckova 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.
PubMed 22018716Atzori 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.
PubMed 20036916Atzori 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.
PubMed 21622109Ciccarelli 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.
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.
PubMed 20046865Gibney 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. doi: 10.1093/ajcn.82.3.497.
PubMed 16155259Walsh 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.
PubMed 16960166
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Infant Feeding on Newborn Metabolomic Profile
- ClinicalTrials.gov ID
- NCT01606683
- Acronym / sponsor ID
- PLA-LENI-09 - SUBSTUDY 1
- Keywords
- Acidified milk, Beta-palmitate, Bifidobacteria, Breastfeeding, Infant formula, Galacto-oligosaccharides, Growth, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heinz Italia SpAIndustry (pharma, biotech, devices)
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, University of Cagliari
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Other: Infant formula with GOS, beta-palmitate, acidified milkInfant 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. |
| GROUP 2 | Other | Other: Standard infant formula without functional ingredientsStandard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients. |
| CONTROL GROUP | Other | Other: No interventionBreast milk |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula with GOS, beta-palmitate, acidified milkInfant 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. | Other | GROUP 1 |
| Standard infant formula without functional ingredientsStandard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients. | Other | GROUP 2 |
| No intervention | Other | CONTROL GROUP |
Primary outcome
Metabolite patterns associated with different dietary regimens
Time frame: At enrolment, after 60 and 135 days of life
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Background: PubMed 15109811Goodacre 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. doi: 10.1016/j.tibtech.2004.03.007. No abstract available.
- Background: PubMed 17134127Ryan D, Robards K. Metabolomics: The greatest omics of them all? Anal Chem. 2006 Dec 1;78(23):7954-8. doi: 10.1021/ac0614341. No abstract available.
- Background: PubMed 22036322Fanos 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.
- Background: PubMed 19701858Atzori 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.
- Background: PubMed 17182837Goodacre R. Metabolomics of a superorganism. J Nutr. 2007 Jan;137(1 Suppl):259S-266S. doi: 10.1093/jn/137.1.259S.
- Background: PubMed 12904817Nicholson 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.
- Background: PubMed 15470467Nicholson 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.
- Background: PubMed 19364557Carraro 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.
- Background: PubMed 22018716Janeckova 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.
- Background: PubMed 20036916Atzori 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.
- Background: PubMed 21622109Atzori 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.
- BackgroundCiccarelli 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Stronati, Prof. principal investigator
FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients in people with Formula Feeding of Healthy Full Term Infants and Breast Feeding of Healthy Full Term Infants, run by Heinz Italia SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolite patterns associated with different dietary regimens (time frame: At enrolment, after 60 and 135 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606683, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.