NCT04749290

Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

Comparative Effects of Cow's Milk Based Infant Formula Containing Both OPO and CPP Versus Non-OPO Formula and Breast Feeding on Growth, Stool Consistency and Bone Strength: A Double-blinded, Randomized and Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Bunge Loders Croklaan · Industry
• Sex: All
• Age: 14 Days – 30 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

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 study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Conditions

• Infant Development

Interventions

Type	Name	Description
OTHER	Study Formula	Study infant formula for term infants containing OPO and CPP

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-10-01
• Completion: 2023-02-15
• First posted: 2021-02-11
• Last updated: 2024-05-16

Locations

2 sites across 1 country: China