NCT04961164

Resistant Starch Prebiotic Effects in Chronic Kidney Disease

A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In patients with Chronic Kidney Disease (CKD), there is a buildup of nitrogenous uremic toxins of gut microbiome origin, which can contribute to uremic symptoms, reduced quality of life, and earlier progression to dialysis. The goal of this project is to investigate whether the consumption of resistant potato starch (RPS) as an adjunctive therapy to current standard of CKD care will reduce uremic toxins and symptoms by altering the gut microbiota in patients with CKD.

Detailed description

Participants will consent to follow a 18-week study regimen. Participants will receive 2 sachets per day containing either 15 grams of RPS or 15 grams corn starch. The powder in the sachets will be mixed in water and consumed, one sachet in the morning and one before bed. Participants will be instructed to consume the investigational product at least 2 hours prior to or after taking any medication. For the first two weeks, all participants will go through a run-in period, where they will receive the corn starch. During weeks 3 to 8 (period 1) participants will receive either RPS or cornstarch. The first treatment received will be determined by randomization procedures. During weeks 9 to 12, all participants will undergo a washout period where they will consume cornstarch. During weeks 13 and 18 (period 2), participants will receive the treatment they did not previously consume.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Resistant Potato Starch, Corn Starch	Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
DIETARY_SUPPLEMENT	Corn Starch, Resistant Potato Starch	Consume corn starch at study period 1, then consume resistant starch at study period 2.

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-11-20
• Completion: 2024-11-30
• First posted: 2021-07-14
• Last updated: 2025-03-17

Locations

2 sites across 1 country: Canada