Bottle Feeding Clinical Trial
Official title:
Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
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.)
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. ;
Observational Model: Cohort, Time Perspective: Retrospective
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