NCT06569797

Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants

The Effect of Adding Milk Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on the Growth and Development of Infants Aged 0-1 Years: a Multicenter, Double-blind, Randomized, Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Heilongjiang Feihe Dairy Co. Ltd. · Industry
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Accepted

Summary

The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.

Detailed description

In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oligosaccharides and multiple nutrients	The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years
DIETARY_SUPPLEMENT	no oligosaccharides and optimizing multiple nutrients	The effect of traditional infant formula milk powder optimized without adding milk oligosaccharides and multiple nutrients on the growth and development of infants aged 0-1 years old.
DIETARY_SUPPLEMENT	breastfeeding	The impact of breastfeeding on the growth and development of infants aged 0-1 years old.

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: China