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

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dc.contributor.authorAlmeida, Jose Bruno de
dc.contributor.authorMorais, Tassia Louise Sousa Augusto de
dc.contributor.authorSouza, Karla Simone Costa de
dc.contributor.authorLima, Mabelle Alves Ferreira de
dc.contributor.authorPereira, Maurıcio Galvão
dc.contributor.authorOliveira, Antonio Manuel Gouveia de
dc.contributor.authorEvangelista, Karine Cavalcanti Mauricio Sena
dc.contributor.authorRezende, Adriana Augusto de
dc.date.accessioned2023-08-02T18:45:45Z
dc.date.available2023-08-02T18:45:45Z
dc.date.issued2022
dc.description.resumoBackground: 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 KTxpt_BR
dc.identifier.citationALMEIDA, José Bruno de; MORAIS, Tássia Louise Sousa Augusto de; SOUZA, Karla Simone Costa de; LIMA, Mabelle Alves Ferreira de; PEREIRA, Maurício Galvão; OLIVEIRA, Antônio Manuel Gouveia de; SENA-EVANGELISTA, Karine Cavalcanti Mauricio; REZENDE, Adriana Augusto de. 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. Plos One, [S.L.], v. 17, n. 8, p. 0272484, 4 ago. 2022. Public Library of Science (PLoS). http://dx.doi.org/10.1371/journal.pone.0272484. Disponível em: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272484. Acesso em: 26 jul. 2023.pt_BR
dc.identifier.doihttps://doi.org/10.1371/journal.pone.0272484
dc.identifier.urihttps://repositorio.ufrn.br/handle/123456789/54340
dc.languageenpt_BR
dc.publisherPlos Onept_BR
dc.rightsAttribution 3.0 Brazil*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/br/*
dc.subjectindividualized nutritional interventionpt_BR
dc.subjecttransplantpt_BR
dc.titleEffects of an individualized nutritional intervention on kidney function, body composition, and quality of life in kidney transplant recipients: study protocol for a randomized clinical trialpt_BR
dc.typearticlept_BR

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