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Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula:
Craig B Adams1, William H Johnston2, Harold Deulofeut3
1Southeastern Pediatric Associates, 364 Honeysuckle Road, Dothan, AL, 36305, USA.
Insights
Reduced protein levels in hypoallergenic infant formulas (2.4 g/100 kcal) using extensively hydrolyzed (EH) or amino acid (AA)-based formulas support appropriate growth in healthy term infants. These formulas were found to be safe and well-tolerated.
Area of Science:
- Pediatric Nutrition
- Infant Formula Development
- Gastroenterology
Background:
- Optimal protein content in hypoallergenic infant formulas is under investigation.
- Evaluating growth in healthy term infants receiving extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein is crucial.
Purpose of the Study:
- To assess the safety, tolerance, and growth outcomes of reduced-protein hypoallergenic formulas in healthy term infants.
- To compare growth rates between infants fed a standard protein formula and those fed reduced-protein EH or AA-based formulas.
Main Methods:
- A prospective, multi-center, double-blind, controlled study involving healthy term infants.
- Infants were randomized to receive a control formula (2.8 g protein/100 kcal) or investigational formulas (2.4 g protein/100 kcal).
- Growth parameters (weight, length, head circumference) and adverse events were monitored from 14 to 120 days of age.
Main Results:
- No significant differences in weight or length growth rates were observed between groups.
- Mean achieved anthropometrics were within WHO growth percentiles, indicating normal development.
- Adverse event reporting and study discontinuation rates due to formula were similar across all groups.
Conclusions:
- Hypoallergenic infant formulas with 2.4 g protein/100 kcal are safe and well-tolerated.
- Reduced protein levels in EH and AA-based formulas support appropriate growth in healthy term infants.
- These findings support the use of reduced-protein hypoallergenic formulas for infant nutrition.
Background:
Optimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein.
Methods:
In this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 107 CFU Lactobacillus rhamnosus GG/100 kcal. Anthropometrics were measured and recall of formula intake, tolerance, and stool characteristics was collected at 14, 30, 60, 90, 120 days of age. Primary outcome was weight growth rate (g/day) between 14 and 120 days of age (analyzed by ANOVA). Medically confirmed adverse events were recorded throughout the study.
Results:
No group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups.
Conclusions:
This study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age.
Trial Registration:
ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366 . Registered 13 May 2011.
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