Assessment of Growth of Infants Fed an Amino Acid-Based Formula

Abstract

Objective: This study's primary aim was to compare the growth (daily weight gain) of infants consuming a new (Test) amino acid-based formula (AAF) or a commercially available AAF (Control).

Methods: Healthy infants were randomized to Test or Control from 14 to 112 days of age. Anthropometric measurements were taken at 14, 28, 56, 84, and 112 days of age. Tolerance records were completed prior to each visit. Serum albumin and plasma amino acids were ascertained in a subset of infants at 84 days of age.

Results: A total of 119 subjects completed the study per protocol. Mean daily weight gains were 27.26 ± 4.92 g/day for Control and 27.42 ± 6.37 g/day for Test (P = 0.8812). There were no significant differences between groups in formula intake, adverse events, flatulence, spit-up/vomiting, mood, or sleep. Albumin and plasma amino acids were within normal limits for both groups.

Conclusions: Infants fed the new AAF had similar daily weight gains as infants fed a commercially available AAF.

Keywords: amino acid-based formula; growth; infant formula.

Figure 1

CONSORT flowchart depicting the number of subjects who withdrew throughout the study.

Figure 2

Boys’ and girls’ body weights by visit. There were no differences in boys’ weights at any visit. In girls, there was a trend for Test girls to have lower body weights at 14, 28, and 56 days (P < 0.07). For girls, there was a statistically significant difference (*P < 0.05) at 84 and 112 days of age.