Impact of Infant Feeding on Newborn Metabolomic Profile

Kraft Heinz

Status: Completed

Conditions: Breast Feeding of Healthy Full Term Infants; Formula Feeding of Healthy Full Term Infants

Treatments: Other: Infant formula with GOS, beta-palmitate, acidified milk; Other: Standard infant formula without functional ingredients; Other: No intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01606683

PLA-LENI-09 - SUBSTUDY 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

GROUP 1

Experimental group

Description:

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.

Treatment:

Other: Infant formula with GOS, beta-palmitate, acidified milk

GROUP 2

Other group

Description:

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

Treatment:

Other: Standard infant formula without functional ingredients

CONTROL GROUP

Other group

Description:

Breast milk

Treatment:

Other: No intervention