Kidney Week

Abstract: SA-PO916

Sixteen Weeks of High Amylose-Resistant Starch Supplementation Leads to a Reduction in p-Cresyl-Sulphate in Predialysis Patients

Session Information

• CKD: Clinical Trials and Pharmacoepidemiology
  November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

• Headley, Sam A., Springfield College, Springfield, Massachusetts, United States

Sam A. Headley,

• Chapman, Donna J., Springfield College, Springfield, Massachusetts, United States

Donna J. Chapman,

• Madsen, Karen, University of Alberta, Edmonton, Alberta, Canada

Karen Madsen,

• Evans, Elizabeth E., Springfield College, Springfield, Massachusetts, United States

Elizabeth E. Evans,

• Cornelius, Allen, Fielding Graduate University, Santa Barbara, California, United States

Allen Cornelius,

• Miele, Emily, Springfield College, Springfield, Massachusetts, United States

Emily Miele,

• Kirton, Kristyn, Springfield College, Springfield, Massachusetts, United States

Kristyn Kirton,

• Loseke, Joshua D., Springfield College, Springfield, Massachusetts, United States

Joshua D. Loseke,

• Martin, Brian J., University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Brian J. Martin,

• Ikizler, Talat Alp, Vanderbilt University Medical Center, Nashville, Tennessee, United States

Talat Alp Ikizler,

• Germain, Michael J., Baystate Medical Center, Springfield, Massachusetts, United States

Michael J. Germain,

Background

Patients with chronic kidney disease (CKD) have high levels of systemic inflammation and oxidative stress. The current study was designed to determine the effect of 16 weeks of supplementation with high amylose resistant starch (HAM-RS2) on the microbiota and biomarkers indicative of inflammation,oxidative stress,and uremic toxins in stage 3-4 patients with CKD.

Methods

This was a double-blind, placebo controlled, parallel arm, randomized controlled trial. Sixty-eight participants were randomized to one of two groups: HAM-RS2 & usual care (RS2) or placebo (cornstarch) & usual care (Con). RS2 was provided as Hi-Maize® 260 RS. For week 1, the dose of supplements was 15 grams/day. The dose was then increased to 33 grams/day for weeks 2-16. Participants attended two baseline (BL) sessions with follow up visits 8 (wk8) and 16 weeks (wk16) later. Fasting blood samples were collected at BL, wk8 and wk16. A stool sample was collected for analysis of microbial composition using 16s RNA sequencing at BL and wk16. The blood samples were analysed for interleukin 6, interleukin 10, tumor necrosis factor alpha, c reactive protein, monocyte chemoattractant protein-1, malondialdehyde, 8-isoprostanes F2a, indoxyl sulphate (IS), and p-cresyl sulphate (PCS).

Results

Sixty-five patients completed the study ( RS2 = 33, Con =32). RS2 led to a significant increase in the levels of butyrate producing bacteria. RS2 also led to a significant reduction in PCS (mg/dl): (BL,3.75 ± 2.88, wk8 3.34 ± 2.65, wk16 2.88 ± 1.78) χ²(2) = 8.74, p = .02, while the control group did not change (BL 3.01 ± 2.18, wk8 2.62 ± 1.71, wk16 3.13 ± 2.52) χ²(2) = 1.13, p = .57. Post hoc analysis indicated that the change from baseline to 16 weeks for PCS in the RS2 group was significant (p = .02). IS followed a similar pattern but did not reach statistical significance. In addition, RS2 did not lead to any significant changes in inflammatory or oxidative stress markers.

Conclusion

Supplementation with RS2 led to a reduction in PCS in our sample of patients with CKD. Since high levels of PCS are associated with increased mortality and progression of CKD,our finding has important clinical implications.

Funding

• Commercial Support – Ingredion donated the resistant starch and the placebo that was used in this study