NCT02111837

Effects of Specific Lipid Fractions-enriched Infant Formulae

Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.

Conditions

• Infant Growth

Interventions

Type	Name	Description
OTHER	Standard infant formula
OTHER	Standard infant formula with PL1
OTHER	Standard infant formula with PL2

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2014-04-11
• Last updated: 2014-04-11

Locations

4 sites across 2 countries: France, Italy