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

Nestlé

Status: Completed

Conditions: Bottle Feeding

Study type: Observational

Funder types: Industry

Identifiers

NCT02010749

9052A1-3001 PHL

Details and patient eligibility

About

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.)

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 2 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study

Exclusion criteria

• Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
• Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
• Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study

Trial design

267 participants in 2 patient groups

Control

Description:

Control: Children who had received Standard formula (SF) as infants

Experimental

Description:

Experimental: Children who had received lower protein formula as infants