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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
Consume corn starch at study period 1, then consume resistant starch at study period 2.
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, Canada
Health Science Centre (HSC)
Winnipeg, Manitoba, Canada
Change in blood uremic toxin, indoxyl sulphate, between treatments
Change in indoxyl sulphate concentrations in serum
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in blood uremic toxin, p-cresyl sulphate, between treatments
Change in p-cresyl sulphate concentrations in serum
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in symptoms score using the Edmonton Symptom Assessment Scale between treatments
Edmonton Symptom Assessment Scale (ESAS). Minimum value 0 and maximum value 100 with higher values being worse. This assessment will be completed through paper or online by RedCAP.
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in quality of life of participants between treatments
Medical Outcomes Study Short Form 36-item questionnaire (SF-36). This questionnaire will be used as self-reported health and wellness assessment. The scoring ranges from 0 to 100. Higher scores indicate better health status.
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in alpha diversity of the gut microbiome between treatments
Shannon index will be computed to measure of richness and evenness of the Operational Taxonomic Units in each sample
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in beta diversity of the gut microbiome between treatments
Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples
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Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in differential abundance in the gut microbiome between treatments
Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package
Time frame: between endpoints of each experimental period (week 8 to week 18)