NCT02332967

Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Week – 4 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Newborn Infants

Interventions

Type	Name	Description
OTHER	Whey predominant starter formula	Milk powder product given to babies between 1 week and 4 months
OTHER	Whey predominant starter formula + 40% palmitic acid	Milk powder product containing 40% of palmitic acid
OTHER	Whey predominant starter formula + 50% palmitic acid	Milk powder product containing 50% of palmitic acid

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-02-01
• Completion: 2012-09-01
• First posted: 2015-01-07
• Last updated: 2015-01-13