NCT01609634

New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety

A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

Summary

This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.

Detailed description

This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Test Product	Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
OTHER	Control Product 1	Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
OTHER	Control Product 2	Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-08-01
• Completion: 2019-12-01
• First posted: 2012-06-01
• Last updated: 2021-10-18

Locations

2 sites across 1 country: Singapore