NCT01079208

Growth of Infants Fed New Starter Formula

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 297 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 11 Days – 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dietary Intervention

Interventions

Type	Name	Description
OTHER	test starter infant formula	infants are fed for 6 months with this starter formula
OTHER	test starter infant formula with synbiotics	infant are fed for 6 months with this formula
OTHER	control standard formula	infant are fed 6 months with this formula

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-12-01
• Completion: 2014-10-01
• First posted: 2010-03-03
• Last updated: 2014-12-03

Locations

3 sites across 1 country: United States