Postgraduate Program in Nutrition, Center for Health Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
Department of Clinical and Toxicological Analysis, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
PLoS One. 2022 Aug 4;17(8):e0272484. doi: 10.1371/journal.pone.0272484. eCollection 2022.
Proteinuria after kidney transplantation (KTx) has been a frequent problem due to several factors, high protein intake being one of them. Individualized nutritional intervention in the late post-KTx period can promote the improvement or the reduction of risks associated with the parameters of evaluation of kidney function, body composition, and quality of life in individuals submitted to KTx.
This is a single-center, randomized and stratified clinical trial. The study will be conducted in a university hospital in northeastern Brazil with 174 individuals aged ≥19 years submitted to KTx and followed up for 12 months. Assessments will take place at 3-month intervals (T0, T3, T6, T9, and T12). The patients will be allocated to intervention and control groups by random allocation. The intervention group will receive individualized nutritional interventions with normoproteic diets (1.0 g/kg) after 60 days of KTx whereas the controls will receive the standard nutritional guidance for the post-KTx period. The primary efficacy variable is the change from baseline in log proteinuria assessed with the urinary albumin/creatinine ratio. Secondary efficacy variables include body composition, anthropometry, quality of life assessment and physical activity, lipid profile and glycemic control. Ninety-two subjects per group will afford 70% power to detect a difference of 25% between groups in log proteinuria. Primary efficacy analysis will be on the modified intention-to-treat population with between-groups comparison of the change from baseline in log proteinuria by analysis of covariance.
The study will assess the effects of an individualized nutritional intervention on proteinuria 12 months after KTx.
REBEC (RBR-8XBQK5).
由于多种因素，肾移植（KTx）后蛋白尿一直是一个常见问题，高蛋白摄入就是其中之一。在 KTx 后晚期进行个体化营养干预可以促进与肾功能评估参数、身体成分和生活质量相关的风险的改善或降低。
这是一项单中心、随机和分层的临床试验。该研究将在巴西东北部的一所大学医院进行，共有 174 名年龄≥19 岁的 KTx 患者接受随访 12 个月。评估将每 3 个月进行一次（T0、T3、T6、T9 和 T12）。患者将通过随机分配分为干预组和对照组。干预组将在 KTx 后 60 天接受个体化营养干预，给予正常蛋白饮食（1.0 g/kg），而对照组将接受 KTx 后标准营养指导。主要疗效变量是用尿白蛋白/肌酐比值评估的蛋白尿从基线的变化。次要疗效变量包括身体成分、人体测量学、生活质量评估和体力活动、血脂谱和血糖控制。每组 92 名受试者将有 70%的功效来检测两组间蛋白尿从基线的差异为 25%。主要疗效分析将针对改良意向治疗人群，通过协方差分析比较两组间蛋白尿从基线的变化。
该研究将评估个体化营养干预对 KTx 后 12 个月蛋白尿的影响。
REBEC（RBR-8XBQK5）。
