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Adequacy and safety of α-lactalbumin-enriched low-protein infant formula: A randomized controlled trial
Hanna Petersen1, Antonia Nomayo1, Richard Zelenka2
1Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.
Insights
This study found that infant formula with reduced protein (1.89 g/100 kcal) enriched with alpha-lactalbumin is safe and supports adequate infant growth, showing no difference in weight gain compared to higher protein formulas or breast milk.
Area of Science:
- Nutritional Science
- Pediatrics
- Infant Nutrition
Background:
- Optimizing infant formula composition is crucial for healthy development.
- Reduced protein content in infant formula is an area of interest for infant health.
- Alpha-lactalbumin is a key whey protein in human milk.
Purpose of the Study:
- To evaluate the suitability and safety of an infant formula with reduced protein content (1.89 g/100 kcal) enriched with alpha-lactalbumin.
- To compare the growth and safety of this formula against a higher protein formula and breast milk.
Main Methods:
- A randomized, double-blind controlled trial involving 80 healthy newborn infants.
- Infants were assigned to receive either a low-protein (1.89 g/100 kcal) or high-protein (2.1 g/100 kcal) formula, with the low-protein formula enriched with alpha-lactalbumin.
- A breast-fed group (40 infants) served as a reference. Anthropometric measures were collected over 12 months.
Main Results:
- No significant differences in weight gain (g/d) were observed among the low-protein formula, high-protein formula, and breast-fed groups at 12 weeks.
- Anthropometric measures (Z-scores for weight, length, head circumference, etc.) and body fat percentage showed no significant differences between groups at the end of the intervention and follow-up.
- Formula consumption and caloric intake were comparable, and food tolerance was adequate.
Conclusions:
- Infant formula enriched with alpha-lactalbumin at a protein content of 1.89 g/100 kcal is safe for healthy newborns.
- This reduced protein formula supports adequate growth, comparable to higher protein formulas and breast milk.
- The findings support the use of this specific infant formula composition for infant nutrition.
Objectives:
The aim of this study was to demonstrate suitability and safety of an infant formula enriched with α-lactalbumin with a reduced protein content of 1.89 g protein/100 kcal.
Methods:
This was a randomized, double-blind controlled trial with 80 healthy newborn infants who were assigned to receive either an isocaloric low- or high-protein content formula (1.89 versus 2.1 g/100 kcal). The low-protein content formula was enriched with α-lactalbumin. A breast-fed reference group of 40 infants was studied concurrently. Anthropometric measures were taken at inclusion, after 6 and 12 wk as well as after 6 and 12 mo of follow-up. Primary outcome was weight gain in g/d between study inclusion to 12 wk. Secondary outcomes included anthropometric measures expressed in Z-scores, mean formula consumption, and caloric intake as well as food tolerance.
Results:
Fifty-two infants in the formula group (low protein: 26, high protein: 26) and 32 in the breast-fed reference group completed the 3-mo intervention period. There was no difference in weight gain among feeding groups at the end of the intervention period. Mean weight gain in g/d was 32 in the low-protein, 31 in the high-protein, and 33 in the breast-fed reference group. No significant difference was found between study groups in Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage at end of intervention and after follow-up.
Conclusion:
α-lactalbumin-enriched formula with a protein content of 1.89 g protein/100 kcal is safe and supports adequate growth.
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