Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

Nestlé

Status: Completed

Conditions: Healthy Newborn Infants

Treatments: Other: Whey predominant starter formula + 40% palmitic acid; Other: Whey predominant starter formula + 50% palmitic acid; Other: Whey predominant starter formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332967

06.16.INF

Details and patient eligibility

About

The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.

Full description

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.

Enrollment: 488 patients

Sex: All

Ages: 1 week to 4 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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488 participants in 3 patient groups

Whey predominant starter formula

Active Comparator group

Description:

Whey predominant starter formula

Treatment:

Other: Whey predominant starter formula + 40% palmitic acid

Other: Whey predominant starter formula + 50% palmitic acid

Whey predominant starter formula + 40% palmitic acid

Experimental group

Description:

Whey predominant starter formula + 40% palmitic acid in sn-2 position

Treatment:

Other: Whey predominant starter formula

Whey predominant starter formula + 50% palmitic acid

Experimental group

Description:

Whey predominant starter formula + 50% palmitic acid in sn-2 position

Treatment:

Other: Whey predominant starter formula