SHORT-TERM EFFECT OF WHEY PROTEIN SUPPLEMENTATION ON THE QUALITY OF LIFE OF PATIENTS WAITING FOR LIVER TRANSPLANTATION: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL.

BACKGROUND: Chronic liver disease is associated with malnutrition that negatively impacts a patient's health-related quality of life (HRQoL). AIM: To evaluate the short-term effect of whey protein supplementation on the HRQoL and nutritional and functional status of patients waiting for liver transplantation. METHODS: This was a double-blind randomized clinical trial with patients waiting for liver transplantation who were randomized into two groups: WP (whey protein supplementation) and the control (casein supplementation). Both groups received 40 g (20 g in the morning and 20 g in the evening) for 15 days. Nutritional and functional status were evaluated. Energy balance was calculated as the difference between energy intake (24-hour recall) and total energy expenditure (assessed by indirect calorimetry). The chronic liver disease questionnaire was used to assess HRQoL. All measurements were performed before and after the intervention. RESULTS: Fifty-six patients were evaluated. Malnutrition was present in 56.9%, and it was directly associated with a poor HRQoL (p<0.05). No improvement on the nutritional and functional status was observed, in either group after protein supplementation. HRQoL improved after WP and casein supplementation, with no differences between groups (p>0.05). Patients who met protein requirements and had a positive energy balance demonstrated a higher HRQoL score (4.9, p<0.05), without between-group differences. CONCLUSION: Malnutrition substantially reduces HRQoL. Short-term WP or casein supplementation improved similarly the HRQoL.

Short-term effect of whey protein supplementation on the quality of life of patients waiting for liver transplantation: a double blinded randomized clinical trial / Efeito a curto prazo da suplementação com proteína do soro do leite sobre a qualidade de vida de pacientes em fila de espera para o transplante hepático: ensaio clínico randomizado

ABSTRACT Background: Chronic liver disease is associated with malnutrition that negatively impacts a patient's health-related quality of life (HRQoL). Aim: To evaluate the short-term effect of whey protein supplementation on the HRQoL and nutritional and functional status of patients waiting for liver transplantation. Methods: This was a double-blind randomized clinical trial with patients waiting for liver transplantation who were randomized into two groups: WP (whey protein supplementation) and the control (casein supplementation). Both groups received 40 g (20 g in the morning and 20 g in the evening) for 15 days. Nutritional and functional status were evaluated. Energy balance was calculated as the difference between energy intake (24-hour recall) and total energy expenditure (assessed by indirect calorimetry). The chronic liver disease questionnaire was used to assess HRQoL. All measurements were performed before and after the intervention. Results: Fifty-six patients were evaluated. Malnutrition was present in 56.9%, and it was directly associated with a poor HRQoL (p<0.05). No improvement on the nutritional and functional status was observed, in either group after protein supplementation. HRQoL improved after WP and casein supplementation, with no differences between groups (p>0.05). Patients who met protein requirements and had a positive energy balance demonstrated a higher HRQoL score (4.9, p<0.05), without between-group differences. Conclusion: Malnutrition substantially reduces HRQoL. Short-term WP or casein supplementation improved similarly the HRQoL.

RESUMO Racional: A doença hepática crônica está associada à desnutrição que afeta negativamente a qualidade de vida relacionada à saúde (QVRS). Objetivo: Avaliar o efeito da suplementação aguda de proteína do soro de leite na QVRS e no estado nutricional e funcional dos pacientes em lista de espera para o transplante hepático. Métodos: Ensaio clínico randomizado com pacientes à espera do transplante hepático que foram randomizados em dois grupos: PS (suplementação com proteína do soro de leite) e Controle (suplementação com caseína). Ambos os grupos receberam 40 g das proteínas (20 g pela manhã e 20 g à noite) por 15 dias. O estado nutricional e funcional foi avaliado. O balanço energético foi calculado como a diferença entre a ingestão energética (recordatório de 24 horas) e o gasto energético total (avaliado por calorimetria indireta). O questionário de doença hepática crônica (CDLQ) foi utilizado para avaliar a QVRS. Todas as medidas foram realizadas antes e após a intervenção. Resultados: Cinquenta e seis pacientes foram avaliados. A desnutrição esteve presente em 56,9% e, diretamente associada à baixa QVRS (p<0,05). A suplementação, com ambas as proteínas, não alterou o estado nutricional e funcional dos pacientes (p>0,05). Entretanto, a QVRS melhorou após a suplementação com PS e caseína, sem diferenças entre os grupos (p>0,05). Pacientes que alcançaram as necessidades proteicas e com balanço energético positivo tiveram maior escore de QVRS (4,9; p<0,05), sem diferenças entre os grupos (p>0,05). Conclusão: A desnutrição reduz substancialmente a QVRS. A suplementação aguda com PS ou caseína melhorou de forma similar a QVRS.

Avaliação do efeito da suplementação proteica na qualidade de vida dos pacientes na fase pré transplante hepático / Evaluation of the effect of protein supplementation on the quality of life of patients in the pre-liver transplant phase

Introdução: A doença hepática crônica cursa com alterações no estado nutricional que impactam negativamente na qualidade de vida (QV) dos pacientes. Assim, a utilização de suplementos alimentares poderia ser alternativa para melhorar a QV. Objetivo: Avaliar o efeito da suplementação de diferentes fontes proteicas na qualidade de vida, no estado nutricional e funcional de pacientes no período pré transplante hepático. Métodos: Tratase de ensaio clínico com pacientes candidatos ao transplante hepático (Tx). Os pacientes foram randomizados para receberem suplementação diária de proteína do soro do leite (PSL) ou caseína (20g de manhã e 20g a noite) durante 15 dias. O estado nutricional foi avaliado por meio da avaliação global subjetiva (AGS), dobra cutânea tricipital (DCT), circunferência do braço (CB) e a funcionalidade por meio da força de pressão palmar, medida pela dinamometria e teste de caminhada de seis minutos (TC6). Para avaliar a qualidade de vida foi aplicado o Chronic Liver Disease Questionnaire (CLDQ). Todas as avaliações foram realizadas antes e após a intervenção. A análise estatística incluiu teste t pareado (p < 0,05). Os dados foram analisados no Stata Statistical Software®, versão 12.0. Resultados: Foram avaliados 56 pacientes, sendo 72,4% do sexo masculino, com idade média 51,9 ±11,3 anos. Cirrose etanólica foi a causa mais frequente (25,9%) da doença hepática. Segundo AGS, 56,9% dos pacientes foram classificados como desnutridos dos quais, 33,4% desnutrição grave e 66,6% desnutrição moderada. Não houve alteração do estado nutricional dos pacientes após a suplementação independente da proteína utilizada (p>0,05). A qualidade de vida aumentou no grupo PSL (3,73 ± 0,98 para 4,70 ± 0,62) e no grupo Caseína (3,70 ± 1,08 para 4,70 ± 0,73) (p < 0,001), sem diferença significativa entre os grupos. A força do aperto de mão no grupo PSL antes da intervenção era 28,99 ± 2,04 e evoluiu para 29,78 ± 2,17 e no grupo Caseína era 29,96 ± 2,67 evoluiu para 31,20 ± 2,42 kg), no entanto, sem diferença significativa (p > 0,05). A média inicial do TC6 no grupo PSL foi de 446,0m±20,75 evoluindo para 454,61±19,63, já no grupo caseína foi de 433,5m4±21,35 e evolui para 449,62m ±16,61 (p>0,05). Conclusão: A doença hepática crônica reduz substancialmente a QV e o presente estudo sugere que a suplementação proteica, independente da fonte, melhora a QVRS em pacientes para o TxH.

Chronic liver disease is associated with changes in nutritional status that negatively impact patients' quality of life (QoL). Thus, the use of dietary supplements may be an alternative to improve the QoL. Objective: To evaluate the effect of supplementation of different protein sources on the quality of life, nutritional status and functional of patients in the pre-transplant period. Methods: This is a clinical trial with patients who are candidates for liver transplantation. Patients were randomized to receive daily supplementation of whey protein (WP) or casein (20 g in the morning and 20 g in the evening) for 15 days. The nutritional status was evaluated through subjective global assessment (SGA), triceps skinfold (TS), arm circumference (AC) and functionality through palmar pressure strength, measured by dynamometry and six-minute walk test (TC6). To evaluate the quality of life the chronic liver disease questionnaire (CLDQ) was applied. All evaluations were performed before and after the intervention. Statistical analysis included paired t test (p <0.05). Data were analyzed in Stata Statistical Software, version 12.0. Results: A total of 56 patients were evaluated, being 72.4% male, with a mean age of 51.90 ± 11.33 years. Ethanolic cirrhosis was the most frequent cause (25.9%) of liver disease. According to SGA, 56.9% of the patients were classified as malnourished, of which 33.4% were severe malnutrition and 66.6% were moderate malnutrition. There was no change in the nutritional status of the patients after supplementation (p> 0.05). Quality of life increased in the WP group (3.73 ± 0.98 to 4.70 ± 0.62) and in the Casein group (3.70 ± 1.08 to 4.70 ± 0.73) (p <0.001), with no significant difference between groups. Regarding dynamometry, the tightening force before intervention in the WP group was 28.99 ± 2.04 and evolved to 29.78 ± 2.17 and in the Casein group it was 29.96 ± 2.67 evolved to 31.20 ± 2.42 kg), however, there was no significant difference (p> 0.05). The initial mean of the 6MWT in the WP group was 446.0 ± 20.75, increasing to 454.61 ± 19.63, whereas the casein group was 433.5m4 ± 21.35 and increased to 449.62m ± 16, 61(p> 0.05). Conclusion: Chronic liver disease substantially reduces QOL and the present study suggests that protein supplementation, regardless of source, improves HRQoL in patients for TxH.