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Assessment of Growth of Infants Fed an Amino Acid-Based Formula
Mark Corkins1, Laura A Czerkies2, Heidi M Storm2
1Division Chief, Division of Pediatric Gastroenterology, Department of Pediatrics, Le Bonheur Children's Hospital, Memphis, TN, USA.; Professor, Department of Pediatrics, The University of Tennessee Health Science Center, Memphis, TN, USA.
Insights
New amino acid-based formula (AAF) supports infant growth comparably to existing options. This study found no significant differences in daily weight gain for infants fed the test AAF versus a control AAF.
Area of Science:
- Pediatrics
- Nutritional Science
- Infant Nutrition
Background:
- Amino acid-based formulas (AAFs) are crucial for infants with specific dietary needs.
- Evaluating the efficacy of novel AAFs is essential for improving infant health outcomes.
Purpose of the Study:
- To compare the daily weight gain of healthy infants fed a new AAF (Test) against a commercially available AAF (Control).
Main Methods:
- Randomized controlled trial involving healthy infants from 14 to 112 days of age.
- Anthropometric measurements and tolerance assessments were conducted throughout the study.
- Biochemical markers (serum albumin, plasma amino acids) were analyzed in a subset of participants.
Main Results:
- No statistically significant difference in mean daily weight gain between the Test (27.42 ± 6.37 g/day) and Control (27.26 ± 4.92 g/day) groups (P = 0.8812).
- Comparable formula intake, adverse events, and tolerance profiles were observed in both groups.
- Serum albumin and plasma amino acid levels remained within normal physiological ranges for all infants.
Conclusions:
- The new amino acid-based formula (AAF) demonstrates comparable efficacy to a commercially available AAF in supporting infant growth.
- The findings support the use of the new AAF as a viable alternative for infant feeding.
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.
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