Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Brief 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 26-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 12 (period 1) participants will receive either RPS or cornstarch. The first treatment received will be determined by randomization procedures. During weeks 13 to 16, all participants will undergo a washout period where they will consume cornstarch. During weeks 17 and 26 (period 2), participants will receive the treatment they did not previously consume.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Estimated Study Start Date: August 1, 2021
Estimated Primary Completion Date: January 31, 2022
Estimated Study Completion Date: April 30, 2022
Arm:
- Experimental: Resistant Potato Starch
- Placebo Comparator: Corn Starch
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 36 |
| Estimated Study start date | 01 August 2021 |
| Estimated Study Completion Date | 30 April 2022 |