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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Potato Starch | Experimental | 15g RPS mixed with water will be consumed twice per day during intervention |
|
| Corn Starch | Placebo Comparator | 15 g corn starch mixed with water will be consumed twice per day during intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Potato Starch, Corn Starch | Dietary Supplement | Consume resistant potato starch at study period 1, then consume corn starch at study period 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood uremic toxin, indoxyl sulphate, between treatments | Change in indoxyl sulphate concentrations in serum | 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 | between endpoints of each experimental period (week 8 to week 18) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between endpoints of each experimental period (week 8 to week 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Waist circumference will be measured in cm. | between endpoints of each experimental period (week 8 to week 18) |
| Change in body weight | Body weight will be measured in kg |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dylan Mackay, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic Disease Innovation Centre, Seven Oaks Hospital | Winnipeg | Manitoba | R2V 3M3 | Canada | ||
| Health Science Centre (HSC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35073986 | Derived | Shamloo M, Mollard R, Wang H, Kingra K, Tangri N, MacKay D. A randomized double-blind cross-over trial to study the effects of resistant starch prebiotic in chronic kidney disease (ReSPECKD). Trials. 2022 Jan 24;23(1):72. doi: 10.1186/s13063-022-06009-1. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Corn Starch, Resistant Potato Starch | Dietary Supplement | Consume corn starch at study period 1, then consume resistant starch at study period 2. |
|
| 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. |
| 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 | 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 | 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 | between endpoints of each experimental period (week 8 to week 18) |
| between endpoints of each experimental period (week 8 to week 18) |
| Change in serum glucose | glucose in mmol/L | between endpoints of each experimental period (week 8 to week 18) |
| Change in Hemoglobin A1c | Hemoglobin A1c as percentage | between endpoints of each experimental period (week 8 to week 18) |
| Change in urinary total protein | Total protein in mg/dL | between endpoints of each experimental period (week 8 to week 18) |
| Change in urinary glucose concentration | Glucose in mmol/L | between endpoints of each experimental period (week 8 to week 18) |
| Change in urinary albumin/creatinine ratio | albumin concentration in milligrams divided by creatinine concentration in grams | between endpoints of each experimental period (week 8 to week 18) |
| Winnipeg |
| Manitoba |
| R3A 1R9 |
| Canada |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |