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Adequacy and safety of α-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.

H. Petersen,A. Nomayo,R. Zelenka,Janine Foster,J. Tvrdík,F. Jochum

Published 2020 in Nutrition (Burbank, Los Angeles County, Calif.)

ABSTRACT

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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