Growth of Infants Fed New Starter Formula

Dietary Intervention Clinical Trial

Official title: Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Clinical Trial Description

Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.

The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Intervention

• NCT number: NCT01079208
• Study type: Interventional
• Source: Nestlé
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Completion date: October 2014