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Open Access Study protocol

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial

Maria Lorella Giannì1*, Paola Roggero1, Charlotte Baudry2, Amandine Ligneul2, Daniela Morniroli1, Francesca Garbarino1, Pascale le Ruyet2 and Fabio Mosca1

Author Affiliations

1 Neonatal Intensive Care Unit (NICU), Department of Clinical Science and Comunity Health, Fondazione IRCCS “Ca’ Granda” Ospedale Maggiore Policlinico, University of Milan, Milan, Italy

2 Lactalis Recherche et Développement, 8 Fromy - CS 60082, 35240, Retiers, France

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BMC Pediatrics 2012, 12:164  doi:10.1186/1471-2431-12-164

Published: 17 October 2012

Abstract

Background

Human milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes.

Methods/Design

In a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study.

Discussion

The achievement of an appropriate long chain polyunsaturated fatty acids status represents an important goal in neonatal nutrition. Gaining further insight in the effects of the supplementation of a formula with dairy lipids and plant oils in healthy full-term infants could help to produce a formula whose fat content, composition and structure is more similar to human milk.

Trial registration

ClinicalTrials.gov Identifier NCT01611649

Keywords:
Full-term infants; Formula supplementation; Dairy lipids; Erythrocyte membrane omega-3 fatty acid profile