Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

Human milk is considered as the golden standard for infant formula. In human milk and infant formula lipids provide about 55% of energy for the infant and represent as such a major nutrient for the baby. The vast majority of the lipids in human milk is composed of triacylglycerols (98% of total lipids) and the remainder percent are phospholipids. Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to 26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are preferentially esterified at the 1 and 3 position. In infant formulas the major source of palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at the 2-position of the triacylgycerol.

The aim of this study is to assess the safety and efficacy of infant formula containing 40% and 50%, respectively, of palmitic acid in sn-2 position.

Inclusion criteria

• healthy newborn infants
• full term infant (37 - 42 weeks gestation)
• birth weight between 2.5 and 4.5 kg
• singleton birth
• the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
• having obtained his7her legal representative's informed consent

Exclusion criteria

• congenital illness or malformation that may affect normal growth
• significant pre-natal and/or post-natal disease
• hospitalization in the first 14 days of life after the child has left the maternity ward
• receiving antibiotic treatment at time of enrolment
• newborn whose parents/caregivers cannot be expected to comply with treatment
• newborn currently participating in another interventional clinical trial.