Sheng Xiao-Yang, Mi Wiola, Yuan Qing Bin, Liu Bryan Yanwen, Carnielli Virgilio, Ning Yi Bing, Einerhand Alexandra W C
Department of Developmental Behavioral Pediatric and Children Healthcare, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Bunge Nutrition, Shanghai, China.
Front Nutr. 2024 Aug 14;11:1442584. doi: 10.3389/fnut.2024.1442584. eCollection 2024.
The aim of this randomized, double-blind, controlled trial was to examine the effects of infant formula on the growth, stool consistency, and bone strength of infants ( = 120) over a period of 4 months. The investigational group was fed an A2 β-casein cow's milk infant formula containing casein phosphopeptides (CPP) and high sn-2 palmitate (54% of total palmitate at sn-2). The control group was fed a standard cow's milk formula without CPP and with low sn-2 palmitate (29% of total palmitate at sn-2). The third group was fed human milk (HM) ( = 60). All three groups had similar baseline characteristics, and maintained similar BMI, sleep habits, and growth rates in body weight and length throughout the study. However, compared to the control group, infants in the investigational and human milk groups had significantly: (i) greater body length at 90, 120, and 150 days of age; (ii) greater growth rate in head circumference from 30 to 60 days of age, with larger head circumference at 60 days of age; (iii) larger daily stool frequency at 60, 90, and 120 days of age; (iv) softer stool at 60, 90, and 120 days of age; (v) higher bone quality index and bone speed of sound at 150 days of age; (vi) fewer hours of crying at 60 and 90 days of age; (vii) less abdominal distention, burp, and flatus at 60, 90, and 120 days of age; and (viii) less constipation at 90 days of age. At other time points, no significant differences were observed between the three groups. No serious adverse events (AEs) related to the study products were reported, and significantly fewer infants in the investigational and HM groups experienced at least one AE compared to the control group. The study suggests that the A2 β-casein formula with high sn-2 palmitate and CPP supports adequate growth, is well tolerated, and may have beneficial effects on stool consistency, gastrointestinal comfort, crying duration, and bone density, comparable to HM. https://clinicaltrials.gov/, NCT04749290.
这项随机、双盲、对照试验的目的是在4个月的时间里，研究婴儿配方奶粉对120名婴儿的生长、粪便稠度和骨骼强度的影响。试验组喂养一种含有酪蛋白磷酸肽（CPP）和高sn-2棕榈酸酯（sn-2位棕榈酸酯占总棕榈酸酯的54%）的A2 β-酪蛋白牛奶婴儿配方奶粉。对照组喂养一种不含CPP且sn-2棕榈酸酯含量低（sn-2位棕榈酸酯占总棕榈酸酯的29%）的标准牛奶配方奶粉。第三组喂养母乳（HM）（n = 60）。在整个研究过程中，所有三组婴儿的基线特征相似，体重指数、睡眠习惯以及体重和身长的生长速度也相似。然而，与对照组相比，试验组和母乳喂养组的婴儿在以下方面有显著差异：（i）在90、120和150日龄时身长更长；（ii）在30至60日龄时头围生长速度更快，60日龄时头围更大；（iii）在60、90和120日龄时每日排便次数更多；（iv）在60、90和120日龄时粪便更软；（v）在150日龄时骨质量指数和骨声速更高；（vi）在60和90日龄时哭闹时间更少；（vii）在60、90和120日龄时腹胀、打嗝和肠胃胀气更少；（viii）在90日龄时便秘更少。在其他时间点，三组之间未观察到显著差异。未报告与研究产品相关的严重不良事件（AE），与对照组相比，试验组和母乳喂养组经历至少一次AE的婴儿明显更少。该研究表明，含有高sn-2棕榈酸酯和CPP的A2 β-酪蛋白配方奶粉有助于充足生长，耐受性良好，并且在粪便稠度、胃肠道舒适度、哭闹持续时间和骨密度方面可能具有与母乳相当的有益效果。https://clinicaltrials.gov/，NCT04749290 。
