NCT02594683

A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition

A Follow-up Study of a Randomised, Controlled, Study to Investigate the Effects of a New Infant Formula Given in the First 12 Months of Life on Growth and Body Composition up to 5 Years of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 359 (actual)
• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. · Industry
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age

Detailed description

A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age. Participants from Venus study will be invited to participate in this follow-up study. Hypothesis: Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.

Conditions

• Healthy

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-09-12
• Completion: 2020-12-01
• First posted: 2015-11-03
• Last updated: 2021-10-18

Locations

2 sites across 1 country: Singapore