NCT02010749

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 267 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 2 Years – 3 Years
• Healthy volunteers: Not accepted

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.)

Detailed 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.

Conditions

• Bottle Feeding

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2013-12-13
• Last updated: 2013-12-13

Locations

1 site across 1 country: Philippines