| Grant number: | 18/12122-7 |
| Support Opportunities: | Regular Research Grants |
| Start date: | November 01, 2018 |
| End date: | October 31, 2020 |
| Field of knowledge: | Health Sciences - Nutrition - Dietetics |
| Principal Investigator: | Lilian Cuppari |
| Grantee: | Lilian Cuppari |
| Host Institution: | Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil |
| City of the host institution: | São Paulo |
| Associated researchers: | Christian Hoffmann ; Lia Sumie Nakao |
Abstract
Introduction: Chronic kidney disease (CKD) seems to induce changes in the composition and metabolic activity of the gut microbiota and to impair the intestinal barrier function. Taking into account that several uremic toxins are originate from colonic fermentation, it has been suggested that these changes in the gut microbiota may contribute to amplify the accumulation of certain toxins, such as p-cresyl sulfate and indoxyl sulfate. The accumulation of these two uremic toxins has been associated to inflammation, cardiovascular disease and mortality from all causes in individuals with CKD. In this context, the gut microbiota emerges as a potential therapeutic target in the treatment of the individuals with CKD. Supplementation with easily fermentable dietary fiber, also named prebiotic, is one of the possible strategies to modulate the activity and the composition of the intestinal microbiota. Currently, few studies investigated the impact of prebiotics on the serum levels of p-cresyl sulfate and indoxyl sulfate in individuals with CKD, with inconclusive results. In a clinical study with patients on hemodialysis the supplementation with resistant starch (dietary fiber) significantly reduced the serum concentration of indoxyl sulfate and a tendency of reduction in free p-cresyl sulfate. As far as we know this is the only study that evaluated the effect of supplementation with resistant starch on the serum levels of these two uremic toxins in dialysis patients. Among products with a significant amount of resistant starch, we can highlight the unripe banana flour (UBF), which is composed of approximately 50% of this carbohydrate. Objectives: To evaluate the effect of intake of UBF on the serum levels of p-cresyl sulfate and indoxyl sulfate, inflammatory biomarkers, intestinal permeability, insulin sensitivity, bowel habit and on the gut microbiota composition of the individuals undergoing peritoneal dialysis. Furthermore, it is part of the objectives of this study to compare the profile of the gut microbiota of individuals undergoing peritoneal dialysis with healthy individuals living in the same environments as patients. Methods: It is a double-blind, randomized, placebo-controlled, crossover clinical trial with a 4-week follow-up and a 4-week washout before cross-over. Fifty patients undergoing peritoneal dialysis will be recruited. The volunteers will consume 20 g/day of UBF or waxy corn starch (placebo). Serum concentration of p-cresyl sulfate and indoxyl sulfate will be determined by high performance liquid chromatography (HPLC). Endotoxemia (LPS) and inflammation markers (IL-6, TNF-±, IL-10 and CRP) will be determined by ELISA. Insulin sensitivity will be evaluated from the plasmatic levels of glucose and insulin by Homeostatic Model Assessment (HOMA). Gastrointestinal symptoms and bowel habit will be assessed by Gastrointestinal Symptom Rating Scale (GSRS), Bristol Scale, and Rome III Criteria. The feces microbial profile will be evaluated by independent technique of cultivation, high yield, in the Illumina MiSeq platform. (AU)
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