Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial

Trials

Roberto Ceratti Manfro¹  Gabriela Corrêa Souza²  Julia Roberta Buboltz³  Júlia de Melo Cardoso de Freitas³  Larissa Salomoni Carpes³  Bruna Bellincanta Nicoletto⁴  Andrea Carla Bauer⁴  Elis Forcellini Pedrollo⁴  Cristiane Bauermann Leitão⁴  Cristina Carra Forte⁴ 

[1] Department of Internal Medicine, School of Medicine, Universidade Federal do Rio Grande do Sul;Department of Nutrition, School of Medicine, Universidade Federal do Rio Grande do Sul;Nutrition Graduate Course, School of Medicine, Federal University of Rio Grande do Sul;Post Graduate Program in Health Sciences, Endocrinology, Universidade Federal do Rio Grande do Sul;

关键词: Kidney transplantation;    Nutrition intervention;    High protein diet;    Low glycemic-index diet;    Weight;   

DOI  :  10.1186/s13063-017-2158-2

来源: DOAJ

【 摘 要 】

Abstract Background Excessive weight gain is commonly observed within the first year after kidney transplantation and is associated with negative outcomes, such as graft loss and cardiovascular events. The purpose of this study is to evaluate the effect of a high protein and low glycemic-index diet on preventing weight gain after kidney transplantation. Methods We designed a prospective, single-center, open-label, randomized controlled study to compare the efficacy of a high protein (1.3–1.4 g/kg/day) and low-glycemic index diet versus a conventional diet (0.8–1.0 g/kg/day of protein) on preventing weight gain after kidney transplantation. A total of 120 eligible patients 2 months after transplantation will be recruited. Patients with an estimated glomerular filtration rate through the modification of diet of renal disease (MDRD) formula < 30 mL/min/1.73 m2 or urinary albumin excretion > 300 mg/24 h will be excluded. Patients’ diets will be allocated through simple sequential randomization. Patients will be followed-up for 12 months with nine clinic appointments with a dietitian and the evaluations will include nutritional assessment (anthropometrics, body composition, and resting metabolic rate) and laboratory tests. The primary outcome is weight maintenance or body weight gain under 5% after 12 months. Secondary outcomes include body composition, resting metabolic rate, satiety sensation, kidney function, and other metabolic parameters. Discussion Diets with higher protein content and lower glycemic index may lead to weight loss because of higher satiety sensation. However, there is a concern about the association of high protein intake and kidney damage. Nevertheless, there is little evidence on the impact of high protein intake on long-term kidney function outcome. Therefore, we designed a study to test if a high protein diet with low-glycemic index will be an effective and safe nutritional intervention to prevent weight gain in kidney transplant patients. Trial Registration ClinicalTrials.gov identifier, NCT02883777 . Registered on 3 August 2016.

【 授权许可】

Unknown