Petersen Hanna, Nomayo Antonia, Zelenka Richard, Foster Janine, Tvrdík Josef, Jochum Frank
Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.
Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.
Nutrition. 2020 Jun;74:110728. doi: 10.1016/j.nut.2020.110728. Epub 2020 Jan 22.
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.
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.
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.
α-lactalbumin-enriched formula with a protein content of 1.89 g protein/100 kcal is safe and supports adequate growth.
本研究旨在证明一种富含α-乳白蛋白、蛋白质含量降低至1.89克蛋白质/100千卡的婴儿配方奶粉的适用性和安全性。
这是一项随机、双盲对照试验，80名健康新生儿被随机分配接受等热量的低蛋白或高蛋白含量配方奶粉（分别为1.89克/100千卡和2.1克/100千卡）。低蛋白含量配方奶粉富含α-乳白蛋白。同时对40名母乳喂养的婴儿组成的参照组进行了研究。在纳入研究时、6周和12周后以及随访6个月和12个月时进行人体测量。主要结局指标是从纳入研究至12周期间每日体重增加的克数。次要结局指标包括以Z评分表示的人体测量指标、平均配方奶粉摄入量、热量摄入以及食物耐受性。
配方奶粉组的52名婴儿（低蛋白组：26名，高蛋白组：26名）和母乳喂养参照组的32名婴儿完成了为期3个月的干预期。干预期结束时，各喂养组之间的体重增加没有差异。低蛋白组每日平均体重增加32克，高蛋白组为31克，母乳喂养参照组为33克。在干预结束时和随访后，各研究组在体重、身长、头围、身长体重比或体重指数的Z评分以及脂肪百分比方面均未发现显著差异。
蛋白质含量为1.89克蛋白质/100千卡的富含α-乳白蛋白的配方奶粉是安全的，并能支持充足的生长发育。
