Department of Paediatrics, KK Women's and Children's Hospital, Singapore 229899, Singapore.
Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.
Nutrients. 2022 Feb 1;14(3):634. doi: 10.3390/nu14030634.
Lipids are essential for healthy infant growth and development. The structural complexity of lipids in human milk is not present in infant milk formula (IF). A concept IF was developed mimicking more closely the structure and composition of human milk fat globules. The current study evaluates whether a concept IF with large, milk phospholipid-coated lipid droplets (mode diameter 3 to 5 μm) is equivalent to standard IF with regard to growth adequacy and safety in healthy, term Asian infants. In this randomized, double-blind, controlled trial, infants were randomized after parents decided to introduce formula. Infants received a standard IF with (Control) or without the specific prebiotic mixture scGOS/lcFOS (9:1 ratio; Control w/o prebiotics), or a Concept IF with large, milk phospholipid-coated lipid droplets and the prebiotic mixture. A group of 67 breastfed infants served as a reference. As a priori defined, only those infants who were fully intervention formula-fed ≤28 days of age were included in the equivalence analysis (Control n = 29; Control w/o prebiotics n = 28; Concept n = 35, per-protocol population). Primary outcome was daily weight gain during the first four months of life, with the difference between the Concept and Control as the key comparison of interest. Additionally, adverse events, growth and tolerance parameters were evaluated. Equivalence of daily weight gain was demonstrated between the Concept and Control group after additional correction for ethnicity and birthweight (difference in estimated means of 0.1 g/d, 90%CI [-2.30, 2.47]; equivalence margin +/- 3 g/d). No clinically relevant group differences were observed in secondary growth outcomes, tolerance outcomes or number, severity or relatedness of adverse events. This study corroborates that an infant formula with large, milk phospholipid-coated lipid droplets supports adequate growth and is well tolerated and safe for use in healthy infants.
脂质对婴儿的健康生长和发育至关重要。人乳中的脂质结构复杂性在婴儿配方奶粉（IF）中并不存在。一种概念 IF 被开发出来，更接近地模拟人乳脂肪球的结构和组成。本研究评估了具有大的、牛奶磷脂包裹的脂质滴（模式直径 3 至 5μm）的概念 IF 是否在健康足月亚洲婴儿的生长充足性和安全性方面与标准 IF 相当。在这项随机、双盲、对照试验中，父母决定引入配方奶后，婴儿被随机分组。婴儿接受标准 IF（对照）或不含特定益生元混合物 scGOS/lcFOS（9:1 比例；对照无益生元），或具有大的、牛奶磷脂包裹的脂质滴和益生元混合物的概念 IF。一组 67 名母乳喂养的婴儿作为参考。如事先定义的，只有那些在 ≤28 天龄时完全接受干预配方喂养的婴儿才包括在等效性分析中（对照 n = 29；对照无益生元 n = 28；概念 n = 35，符合方案人群）。主要结局是生命最初四个月的每日体重增加，概念和对照之间的差异是感兴趣的关键比较。此外，还评估了不良事件、生长和耐受性参数。在对种族和出生体重进行额外校正后，证明了概念组和对照组之间的每日体重增加具有等效性（估计均值差异为 0.1g/d，90%CI[-2.30，2.47]；等效性边界 +/-3g/d）。在次要生长结局、耐受性结局或不良事件的数量、严重程度或相关性方面，未观察到临床相关的组间差异。本研究证实，具有大的、牛奶磷脂包裹的脂质滴的婴儿配方奶粉支持充足的生长，并且在健康婴儿中使用是耐受良好且安全的。
