Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

Bottle Feeding Clinical Trial

Official title: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

Status Completed

Clinical Trial Summary

The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(* The mean age of subjects was 33.0 months due to a delay in the study start-up.)

Clinical Trial Description

This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bottle Feeding

• NCT number: NCT02010749
• Study type: Observational
• Source: Nestlé
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Completion date: December 2010