Efficacy and safety of a low-sodium diet and spironolactone in patients with stage 1-3a chronic kidney disease: a pilot study.

BACKGROUND: Excessive salt intake is associated with the deterioration of chronic kidney disease (CKD). Aldosterone is also known as an independent risk factor for kidney injury. Dietary sodium intake acts as a main stimulator in aldosterone-mediated kidney injury. Hence, this study aimed to further investigate the renal protective effects and safety of a low-sodium diet in combination with spironolactone (SPL) in stage 1-3a CKD. METHODS: This single-center, SPL-blinded randomized controlled trial recruited patients with stage 1-3a CKD, randomized into three groups, low-sodium (3 g/d salt) + placebo, medium-sodium (5 g/d salt) + SPL, and low-sodium (3 g/d salt) + SPL. Patients received 12 weeks of intervention. The primary and secondary endpoints were 24-h urine protein and estimated glomerular filtration rate (eGFR) at the end of the intervention, respectively. RESULTS: A total of 74 patients were analyzed eventually. Significantly decreased 24-h urine protein was found in all three groups, from 0.37 to 0.23 g/d (P = 0.004) in the low-sodium+placebo group, from 0.44 to 0.29 g/d (P = 0.020) in the medium-sodium+SPL group, and from 0.35 to 0.31 g/d (P = 0.013) in the low-sodium +SPL group. There were no significant differences among the three groups in 24-h urine protein amount change after intervention from pre-treatment values (P = 0.760, ITT set). The results of the 24-h urine protein by using PP set analysis was similar to the ITT set. No significant differences in eGFR, nutritional, metabolic, inflammatory, and other biomarkers were observed across all three groups (P > 0.05). No safety signal was observed. CONCLUSION: No additional benefit was observed when SPL was prescribed to patients already on a low-sodium diet (3.0 g/d). Still, small doses of SPL may benefit patients with poor sodium restriction. A combination of short-term low-dose SPL and ARB is safe for patients with stage 1-3a CKD, but blood potassium must be regularly monitored. TRIAL REGISTRATION: Name of the registry: Chinese clinical trial registry. TRIAL REGISTRATION NUMBER: ChiCTR1900026991. Date of registration: Retrospectively registered 28 October 2019. URL of trial registry record: http://www.chictr.org.cn/searchproj.aspx?title=&officialname=&subjectid=&secondaryid=&applier=&studyleader=ðicalcommitteesanction=&spo.

Low-protein diet supplemented with inulin lowers protein-bound toxin levels in patients with stage 3b-5 chronic kidney disease: a randomized controlled study.

Introduction: Objective: this study aimed to evaluate whether low-salt low-protein diet (LPD) supplemented with 10 g of inulin could lower serum toxin levels in patients with chronic kidney disease (CKD), thereby providing evidence for adjusting dietary prescriptions of inhospital patients and outpatient nutrition consultants. Methods: we randomized 54 patients with CKD into two groups. Dietary protein intake compliance was evaluated using a 3-day dietary diary and 24-h urine nitrogen levels. The primary outcomes were indoxyl sulfate (IS) and p-cresyl sulfate (PCS), and secondary outcomes included inflammation marker levels, nutritional status, and renal function. We assessed 89 patients for eligibility, and a total of 45 patients completed the study, including 23 and 22 in the inulin-added and control groups, respectively. Results: PCS values decreased in both groups after intervention: inulin-added group, ∆PCS -1.33 (-4.88, -0.63) µg/mL vs. LPD group, -4.7 (-3.78, 3.69) µg/mL (p = 0.058). PCS values reduced from 7.52 to 4.02 µg/mL (p < 0.001) in the inulin-added group (p < 0.001). Moreover, IS decreased from 3.42 (2.53, 6.01) µg/mL to 2.83 (1.67, 4.74) µg/mL after adding inulin; ∆IS was -0.64 (-1.48, 0.00) µg/mL, and a significant difference was observed compared with the control group (p = 0.004). The inflammation index decreased after intervention. Conclusion: dietary fiber supplementation may reduce serum IS and PCS levels and modulate their inflammatory status in predialysis CKD patients.

Introducción: Objetivo: este ensayo aleatorizado doble ciego comparó el efecto de una dieta baja en proteínas (LPD) con o sin suplementos orales de 10 g de inulina en los niveles de PBUT en pacientes con ERC en prediálisis durante 12 semanas. Métodos: clasificamos aleatoriamente a 54 pacientes con ERC en dos grupos. El cumplimiento de la ingesta dietética de proteínas se evaluó utilizando un diario dietético de 3 días y nitrógeno en orina de 24 horas. Los resultados primarios fueron IS y PCS y los resultados secundarios incluyeron niveles de marcadores de inflamación, estado nutricional y función renal. Evaluamos la elegibilidad de 89 pacientes y 45 completaron la intervención, incluidos 23 y 22 en los grupos de inulina añadida y de control, respectivamente. Resultados: el sodio urinario promedio de 24 horas fue de 86 mmol/día y la ingesta promedio de proteínas fue de ~0,7 g/kg/día. Los valores de PCS exhibieron una tendencia decreciente en ambos grupos después de la intervención: grupo con inulina añadida, ∆PCS -1.33 (-4.88, -0.63) µg/mL vs. grupo LPD, -4.7 (-3.78, 3.69) µg/mL) (p =0,058). Los valores de PCS se redujeron de 7,52 a 4,02 µg/mL (p < 0,001) con inulina (p < 0,001). Además, IS disminuyó de 3,42 (2,53, 6,01) µg/mL a 2,83 (1,67, 4,74) µg/mL después de agregar inulina; El ∆IS fue -0,64 (-1,48; 0,00) µg/mL y se observó una diferencia significativa en comparación con el grupo control (p =0,004). Conclusión: la suplementación con fibra dietética puede reducir las toxinas de unión a proteínas séricas en pacientes con ERC en prediálisis y modular su estado inflamatorio.

Low-protein diet supplemented with inulin lowers protein-bound toxin levels in patients with stage 3b-5 chronic kidney disease: a randomized controlled study / La dieta baja en proteínas suplementada con inulina reduce los niveles de toxinas unidas a proteínas en pacientes con enfermedad renal crónica en estadio 3b-5: un estudio controlado aleatorio

Objective: this study aimed to evaluate whether low-salt low-protein diet (LPD) supplemented with 10 g of inulin could lower serum toxin levels in patients with chronic kidney disease (CKD), thereby providing evidence for adjusting dietary prescriptions of inhospital patients and outpatient nutrition consultants. Methods: we randomized 54 patients with CKD into two groups. Dietary protein intake compliance was evaluated using a 3-day dietary diary and 24-h urine nitrogen levels. The primary outcomes were indoxyl sulfate (IS) and p-cresyl sulfate (PCS), and secondary outcomes included inflammation marker levels, nutritional status, and renal function. We assessed 89 patients for eligibility, and a total of 45 patients completed the study, including 23 and 22 in the inulin-added and control groups, respectively. Results: PCS values decreased in both groups after intervention: inulin-added group, ∆PCS -1.33 (-4.88, -0.63) μg/mL vs. LPD group, -4.7 (-3.78, 3.69) μg/mL (p = 0.058). PCS values reduced from 7.52 to 4.02 μg/mL (p < 0.001) in the inulin-added group (p < 0.001). Moreover, IS decreased from 3.42 (2.53, 6.01) μg/mL to 2.83 (1.67, 4.74) μg/mL after adding inulin; ∆IS was -0.64 (-1.48, 0.00) μg/mL, and a significant difference was observed compared with the control group (p = 0.004). The inflammation index decreased after intervention. Conclusion: dietary fiber supplementation may reduce serum IS and PCS levels and modulate their inflammatory status in predialysis CKD patients.(AU)

Objetivo: este ensayo aleatorizado doble ciego comparó el efecto de una dieta baja en proteínas (LPD) con o sin suplementos orales de 10 gde inulina en los niveles de PBUT en pacientes con ERC en prediálisis durante 12 semanas.Métodos: clasificamos aleatoriamente a 54 pacientes con ERC en dos grupos. El cumplimiento de la ingesta dietética de proteínas se evaluóutilizando un diario dietético de 3 días y nitrógeno en orina de 24 horas. Los resultados primarios fueron IS y PCS y los resultados secundariosincluyeron niveles de marcadores de inflamación, estado nutricional y función renal. Evaluamos la elegibilidad de 89 pacientes y 45 completaronla intervención, incluidos 23 y 22 en los grupos de inulina añadida y de control, respectivamente.Resultados: el sodio urinario promedio de 24 horas fue de 86 mmol/día y la ingesta promedio de proteínas fue de ~0,7 g/kg/día. Los valores dePCS exhibieron una tendencia decreciente en ambos grupos después de la intervención: grupo con inulina añadida, ∆PCS -1.33 (-4.88, -0.63)μg/mL vs. grupo LPD, -4.7 (-3.78, 3.69) μg/mL) (p =0,058). Los valores de PCS se redujeron de 7,52 a 4,02 μg/mL (p < 0,001) con inulina(p < 0,001). Además, IS disminuyó de 3,42 (2,53, 6,01) μg/mL a 2,83 (1,67, 4,74) μg/mL después de agregar inulina; El ∆IS fue -0,64 (-1,48;0,00) μg/mL y se observó una diferencia significativa en comparación con el grupo control (p =0,004).Conclusión: la suplementación con fibra dietética puede reducir las toxinas de unión a proteínas séricas en pacientes con ERC en prediálisisy modular su estado inflamatorio.(AU)