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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Elis Forcellini Pedrollo, Bruna Bellincanta Nicoletto, Larissa Salomoni Carpes, Júlia de Melo Cardoso de Freitas, Julia Roberta Buboltz, Cristina Carra Forte, Andrea Carla Bauer, Roberto Ceratti Manfro, Gabriela Corrêa Souza, Cristiane Bauermann Leitão

Published in: Trials | Issue 1/2017

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Elis Forcellini Pedrollo
Bruna Bellincanta Nicoletto
Larissa Salomoni Carpes
Júlia de Melo Cardoso de Freitas
Julia Roberta Buboltz
Cristina Carra Forte
Andrea Carla Bauer
Roberto Ceratti Manfro
Gabriela Corrêa Souza
Cristiane Bauermann Leitão
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2158-2

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