Effects of High Amylose-Resistant Starch on Gut Microbiota and Uremic Toxin Levels in Patients With Stage-G3a-G4 Chronic Kidney Disease: A Randomized Trial

Abstract

Objective: This study was designed to determine the effect of 16 weeks of supplementation with Hi-maize 260 resistant starch (RS) on the gut microbiota, uremic toxins (indoxyl sulfate and p-cresyl sulfate [PCS]), markers of inflammation, and oxidative stress along with vascular function in patients with stage G3a-G4 chronic kidney disease (CKD). Design and Methods: This was a double-blind, placebo-controlled, parallel-arm, randomized controlled trial. Sixty-eight patients with stage-G3a-G4 CKD were randomized to either RS with usual care or placebo and usual care. Patients attended four testing sessions as follows: two baseline (BL) visits and follow-up visits at 8 and 16 weeks. Fasting blood samples, resting brachial and central blood pressures, along with arterial stiffness, were collected at visits (1 or 2) and weeks 8 and 16. A stool sample was collected for analysis of microbial composition at BL and week 16. Patients were randomized after the BL visits. Results: Patients receiving the RS had a reduction in PCS at week 16. This reduction was associated with a decrease in microbial α-diversity between BL and week 16 (Chao1 P = .014, Shannon P = .017, phylogenetic diversity P = .046, and Simpson P = .017) as well as increases in Subdoligranulum (P = .03) and Oscillospiraceae Unclassified Clostridiales Group 002 (P = .02) and decreases in Bacteroides (P = .009).There were no changes in microbial beta diversity and other biomarkers or markers of vascular function following the 16-week period. Conclusion: Sixteen weeks of supplementation of RS in patients with stage-G3a-G4 CKD led to changes in microbial composition that were associated with a significant reduction in PCS.