Liotto Nadia, Orsi Anna, Menis Camilla, Piemontese Pasqua, Morlacchi Laura, Condello Chiara Cristiana, Giannì Maria Lorella, Roggero Paola, Mosca Fabio
Fondazione I.R.C.C.S. Ca Granda Ospedale Maggiore Policlinico, Neonatal Intensive Care Unit Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
Centro di Nutrizione a Partenza neonatale, Clinica Mangiagalli, Via Della Commenda, 12, 20122, Milan, Italy.
BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.
A high early protein intake is associated with rapid postnatal weight gain and altered body composition. We aimed to evaluate the safety of a low-protein formula in healthy full-term infants.
A randomized controlled trial was conducted. A total of 118 infants were randomized to receive two different protein content formulas (formula A or formula B (protein content: 1.2 vs. 1.7 g/100 mL, respectively)) for the first 4 months of life. Anthropometry and body composition by air displacement plethysmography were assessed at enrolment and at two and 4 months. The reference group comprised 50 healthy, exclusively breastfed, full-term infants.
Weight gain (g/day) throughout the study was similar between the formula groups (32.5 ± 6.1 vs. 32.8 ± 6.8) and in the reference group (30.4 ± 5.4). The formula groups showed similar body composition but a different fat-free mass content from breastfed infants at two and 4 months. However, the formula A group showed a fat-free mass increase more similar to that of the breastfed infants. The occurrence of gastrointestinal symptoms or adverse events was similar between the formula groups.
Feeding a low-protein content formula appears to be safe and to promote adequate growth, although determination of the long-term effect on body composition requires further study.
The present study was retrospectively registered in ClinicalTrials.gov (trial number: NCT03035721 on January 18, 2017).
早期高蛋白摄入与出生后体重快速增加及身体成分改变有关。我们旨在评估低蛋白配方奶粉对健康足月婴儿的安全性。
进行了一项随机对照试验。总共118名婴儿被随机分配，在出生后的前4个月接受两种不同蛋白质含量的配方奶粉（配方奶粉A或配方奶粉B，蛋白质含量分别为1.2 g/100 mL和1.7 g/100 mL）。在入组时以及2个月和4个月时评估人体测量指标和通过空气置换体积描记法测量的身体成分。参照组包括50名健康的、纯母乳喂养的足月婴儿。
整个研究期间，配方奶粉组之间（32.5±6.1对32.8±6.8）以及与参照组（30.4±5.4）的体重增加（克/天）相似。配方奶粉组在2个月和4个月时身体成分相似，但与母乳喂养婴儿的去脂体重含量不同。然而，配方奶粉A组的去脂体重增加与母乳喂养婴儿的更为相似。配方奶粉组之间胃肠道症状或不良事件的发生率相似。
喂养低蛋白含量的配方奶粉似乎是安全的，并且能促进充足生长，尽管对身体成分的长期影响仍需进一步研究。
本研究于2017年1月18日在ClinicalTrials.gov进行了回顾性注册（试验编号：NCT03035721）。
