NCT04593147

Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Building Block Nutritionals, LLC · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

Detailed description

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.

Conditions

• Infant Development

Interventions

Type	Name	Description
OTHER	BBN	BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
OTHER	Brand	Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks

Timeline

• Start date: 2020-10-14
• Primary completion: 2021-11-09
• Completion: 2021-11-09
• First posted: 2020-10-19
• Last updated: 2021-11-15

Locations

1 site across 1 country: United States