Study Summary
This trial will test whether resistant potato starch can help reduce symptoms in patients with Chronic Kidney Disease by altering the gut microbiota.
Eligible Conditions
- Chronic Kidney Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: between endpoints of each experimental period (week 12 to week 26)
Week 26
Change in Hemoglobin A1c
Change in alpha diversity of the gut microbiome between treatments
Change in beta diversity of the gut microbiome between treatments
Change in blood uremic toxin, indoxyl sulphate, between treatments
Change in blood uremic toxin, p-cresyl sulphate, between treatments
Change in body weight
Change in differential abundance in the gut microbiome between treatments
Change in quality of life of participants between treatments
Change in serum glucose
Change in symptoms score using the Edmonton Symptom Assessment Scale between treatments
Change in urinary albumin/creatinine ratio
Change in urinary glucose concentration
Change in urinary total protein
Change in waist circumference
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Resistant Potato Starch
1 of 2
Corn Starch
1 of 2
Experimental Treatment
Non-Treatment Group
36 Total Participants · 2 Treatment Groups
Primary Treatment: Resistant Potato Starch, Corn Starch · Has Placebo Group · N/A
Resistant Potato Starch
DietarySupplement
Experimental Group · 1 Intervention: Resistant Potato Starch, Corn Starch · Intervention Types: DietarySupplementCorn Starch
DietarySupplement
PlaceboComparator Group · 1 Intervention: Corn Starch, Resistant Potato Starch · Intervention Types: DietarySupplementTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: between endpoints of each experimental period (week 12 to week 26)
Who is running the clinical trial?
University of ManitobaLead Sponsor
540 Previous Clinical Trials
187,126 Total Patients Enrolled
Dylan Mackay, PhDPrincipal InvestigatorUniversity of Manitoba
5 Previous Clinical Trials
205 Total Patients Enrolled
Eligibility Criteria
Age 18 - 85 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have an eGFR <15 mL/min/1.73m^2 for the past 3 months.
You are willing and able to give informed consent for participation in the trial.
You are willing and able to comply with all trial requirements.
References
- Shamloo, Maryam, Rebecca Mollard, Haizhou Wang, Kulwant Kingra, Navdeep Tangri, and Dylan MacKay. 2022. “A Randomized Double-blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic in Chronic Kidney Disease (respeckd)”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06009-1.
- Dylan MacKay. PhD 2022. "Resistant Starch Prebiotic Effects in Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04961164.
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Conditions
Cancer Related
Treatments