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Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial

BACKGROUND: 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 paramete...

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Autores principales: de Morais, Tássia Louise Sousa Augusto, de Souza, Karla Simone Costa, de Lima, Mabelle Alves Ferreira, Pereira, Maurício Galvão, de Almeida, José Bruno, de Oliveira, Antônio Manuel Gouveia, Sena-Evangelista, Karine Cavalcanti Mauricio, de Rezende, Adriana Augusto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9352089/
https://www.ncbi.nlm.nih.gov/pubmed/35925872
http://dx.doi.org/10.1371/journal.pone.0272484
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author de Morais, Tássia Louise Sousa Augusto
de Souza, Karla Simone Costa
de Lima, Mabelle Alves Ferreira
Pereira, Maurício Galvão
de Almeida, José Bruno
de Oliveira, Antônio Manuel Gouveia
Sena-Evangelista, Karine Cavalcanti Mauricio
de Rezende, Adriana Augusto
author_facet de Morais, Tássia Louise Sousa Augusto
de Souza, Karla Simone Costa
de Lima, Mabelle Alves Ferreira
Pereira, Maurício Galvão
de Almeida, José Bruno
de Oliveira, Antônio Manuel Gouveia
Sena-Evangelista, Karine Cavalcanti Mauricio
de Rezende, Adriana Augusto
author_sort de Morais, Tássia Louise Sousa Augusto
collection PubMed
description BACKGROUND: 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. METHODS: 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. DISCUSSION: The study will assess the effects of an individualized nutritional intervention on proteinuria 12 months after KTx. TRIAL REGISTRATION: REBEC (RBR-8XBQK5).
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spelling pubmed-93520892022-08-05 Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial de Morais, Tássia Louise Sousa Augusto de Souza, Karla Simone Costa de Lima, Mabelle Alves Ferreira Pereira, Maurício Galvão de Almeida, José Bruno de Oliveira, Antônio Manuel Gouveia Sena-Evangelista, Karine Cavalcanti Mauricio de Rezende, Adriana Augusto PLoS One Registered Report Protocol BACKGROUND: 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. METHODS: 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. DISCUSSION: The study will assess the effects of an individualized nutritional intervention on proteinuria 12 months after KTx. TRIAL REGISTRATION: REBEC (RBR-8XBQK5). Public Library of Science 2022-08-04 /pmc/articles/PMC9352089/ /pubmed/35925872 http://dx.doi.org/10.1371/journal.pone.0272484 Text en © 2022 Morais et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Registered Report Protocol
de Morais, Tássia Louise Sousa Augusto
de Souza, Karla Simone Costa
de Lima, Mabelle Alves Ferreira
Pereira, Maurício Galvão
de Almeida, José Bruno
de Oliveira, Antônio Manuel Gouveia
Sena-Evangelista, Karine Cavalcanti Mauricio
de Rezende, Adriana Augusto
Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title_full Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title_fullStr Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title_full_unstemmed Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title_short Effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: Study protocol for a randomized clinical trial
title_sort effects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: study protocol for a randomized clinical trial
topic Registered Report Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9352089/
https://www.ncbi.nlm.nih.gov/pubmed/35925872
http://dx.doi.org/10.1371/journal.pone.0272484
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