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Growth and protein status of term infants fed soy protein formulas differing in protein content.

OBJECTIVE
The purpose of this study was to compare growth and protein status of healthy term infants from 2 to 112 days of age fed a commercially available soy-based formula (IS) and a similar formula (EF) containing less protein (2.91 vs 2.45 g/100 kcal).


DESIGN
A controlled, randomized, blind parallel clinical trial was conducted in 32 male and 32 female infants. Infants were enrolled at 2 days of age, and their assigned formula was their only feeding to 112 days of age. At this time their weight, length, and head circumference were measured. Weight, length, and head circumference were measured and formula intake, formula intolerance and stool characteristics were recorded at 8, 28, 56, and 112 days of age. Plasma urea nitrogen (PUN), total protein, albumin, and transthyretin were determined at 56 and 112 days.


RESULTS
There were no statistically significant differences in weight, length, head circumference, or gains in these measures. PUN concentration was significantly lower in infants fed EF than IS at 56 and 112 days. Plasma total protein, albumin, and transthyretin concentrations were not different between the two feeding groups at the two testing periods. Tolerance to the two formulas was similar. Stool characteristics did not differ between the two groups.


CONCLUSION
A soy-based formula containing 2.45 g protein/100 kcal and approximately 640 mumol of total sulfur containing amino acids/100 kcal adequately meets the protein needs of term infants from 2 to 112 days of age.