Effect on nutritional status and biomarkers of inflammation and oxidation of an oral nutritional supplement (with or without probiotics) in malnourished hemodialysis patients. A multicenter randomized clinical trial Renacare Trial

Background: Malnutrition in patients undergoing hemodialysis is frequent and associated with a reduction in muscular mass and strength, with an increment in biomarkers of inflammation and oxidation.Materials and methods: Randomized, multicenter, parallel-group trial in malnourished hemodialysis patients with three groups [(1) control (C) individualized diet, (2) oral nutritional supplement-ONS- + placebo-SU- PL-, and (3) ONS + probiotics-SU-PR]; the trial was open regarding the intake of ONS or individualized diet recommendations, but double-blind for the intake of probiotics. We obtained, at baseline and after 3 and 6 months, anthropometric measurements, handgrip strength, bioelectrical impedance analysis (BIA), dietary records, and routine biochemical parameters. Inflammation and oxidation were determined using ELISA techniques (Versamax and ProcartaPlex multiplex Immunoassay). Results were analyzed by intention to treat.Results: A total of 31 patients (11 corresponding to group C, 10 to SU-PL, and 10 to SU-PR) completed the 6-months trial. The two groups that took supplements significantly increased their protein calorie, fat (total and n-3), and fiber intake. Weight and fat-free mass (FFM) also increased significantly in the groups on supplements, both at 3 and 6 months, and dynamometry did so in the SU-PL group. At month 3, prealbumin and vitamin D were significantly increased in the SU-TOT (SU-PL + SU-PR) group. No changes were observed regarding levels of phosphorus and potassium in any of the groups. Urea increased significantly at 6 months in the SU-PL group. There were significant changes in some inflammation biomarkers in the groups on supplements during the intervention (brain-derived neurotrophic factor, bone morphogenetic protein-2, MCP-1, IL-1-beta, IL-10, IL-4, and IL-8). The total antioxidant capacity (TAC) increased significantly in the supplemented patients, with no significant changes observed in isoprostanes.Conclusion: The specific ONS improved protein-calorie intake, nutritional status (mainly FFM), and some biomarkers of inflammation/oxidation. The addition of probiotics could have a synergistic effect with ONS in such biomarkers.Clinical trail registration: , identifier NCT03924089.

Automated summary

This study aimed to investigate the effects of oral nutritional supplements (ONS) and probiotics on nutritional status and biomarkers of inflammation/oxidation in malnourished hemodialysis patients. The results showed that ONS significantly increased protein and calorie intake, improved body weight and fat-free mass, and had significant effects on some inflammation/oxidation biomarkers. The addition of probiotics may have a synergistic effect with ONS on these biomarkers.