NCT01197365

Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Heinz Italia SpA · Industry
• Sex: All
• Age: 21 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.

Detailed description

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable. New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk. The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation. The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.

Conditions

• Formula Feeding of Healthy Full Term Infants

Interventions

Type	Name	Description
OTHER	Infant formula with GOS, beta-palmitate, acidified milk	Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
OTHER	Standard infant formula without functional ingredients	Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-03-01
• Completion: 2014-12-01
• First posted: 2010-09-09
• Last updated: 2015-02-04

Locations

1 site across 1 country: Italy