这个随机化的目的,双盲,对照试验是检查婴儿配方奶粉对生长的影响,大便稠度,以及4个月内婴儿(n=120)的骨强度。研究组饲喂含酪蛋白磷酸肽(CPP)和高sn-2棕榈酸酯(占sn-2总棕榈酸酯的54%)的A2β-酪蛋白牛乳婴儿配方奶粉。对照组饲喂不含CPP和低sn-2棕榈酸酯的标准牛奶配方(占sn-2总棕榈酸酯的29%)。第三组饲喂人乳(HM)(n=60)。所有三组都有相似的基线特征,并保持相似的BMI,睡眠习惯,以及整个研究过程中体重和身长的增长率。然而,与对照组相比,调查组和母乳组的婴儿具有显著的:(i)在90、120和150日龄时的体长更大;(ii)30至60日龄的头围增长率更大,60日龄时头围较大;(iii)60日龄、90日龄和120日龄时每日大便次数较大;(iv)60日龄、90日龄和120日龄时大便较软;(v)150日龄时骨骼质量指数和骨骼声速较高;(vi)60日龄和90日龄时哭闹时间较少;(vii)腹胀较少,打嗝,和在60、90和120日龄时的排气;和(viii)在90日龄时的便秘较少。在其他时间点,三组间无显著差异.未报告与研究产品相关的严重不良事件(AE)。与对照组相比,研究组和HM组中经历至少一次AE的婴儿明显较少。研究表明,具有高sn-2棕榈酸酯和CPP的A2β-酪蛋白配方支持足够的生长,耐受性良好,并可能对粪便稠度产生有益影响,肠胃舒适,哭泣的持续时间,和骨密度,相当于HM。临床试验注册:https://clinicaltrials.gov/,NCT04749290。
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 (n = 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) (n = 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. Clinical
trial registration: https://clinicaltrials.gov/, NCT04749290.