Resistant Starch for Chronic Kidney Disease

(ReSPECKD Trial)

No longer recruiting at 1 trial location

Overseen By Rebecca Mollard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Opioids, Loperamide, Antibiotics, others

Disqualifiers: Dialysis, Bowel diseases, Cancer, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding resistant potato starch, a type of dietary fiber, to the diet can help people with Chronic Kidney Disease (CKD) feel better by reducing harmful toxins in their bodies. Participants will consume either potato starch or a placebo (corn starch) mixed with water twice daily. It suits those with CKD experiencing significant kidney function decline (eGFR less than 15, a measure of kidney function) who have not had a kidney transplant or started dialysis. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve the quality of life for CKD patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants taking certain medications like opioids or those who consume probiotic supplements. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that resistant potato starch (RPS) is safe for people with chronic kidney disease (CKD). Research indicates that RPS can positively alter the gut microbiota—the community of tiny organisms in the stomach—without causing harmful effects. This change can reduce blood toxin levels, benefiting kidney health.

These studies have not shown clear evidence of serious side effects from RPS. It appears well-tolerated, meaning most people can take it without issues. For those considering joining a clinical trial involving RPS, this information may help ease concerns about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic kidney disease, which often focus on managing symptoms with medications like ACE inhibitors or dietary changes, resistant potato starch offers a novel approach by potentially improving gut health. Resistant potato starch is unique because it acts as a prebiotic, fostering beneficial gut bacteria that may help reduce inflammation and improve overall kidney function. Researchers are excited about this treatment because it could provide a natural, low-risk option that complements existing therapies, targeting the condition from a different angle.

What evidence suggests that resistant potato starch might be an effective treatment for chronic kidney disease?

Research has shown that resistant potato starch (RPS), which participants in this trial may receive, might benefit people with chronic kidney disease (CKD). Some studies suggest that RPS can alter gut bacteria, potentially lowering harmful substances that accumulate in the blood. One study found that RPS improved kidney function by reducing these harmful substances. Although it does not appear to lower inflammation, it shows potential in enhancing gut health. Overall, RPS could be a promising addition to standard CKD care. ^{1 3 5 6 7}

Who Is on the Research Team?

Dylan Mackay, PhD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

Adults over 18 with Chronic Kidney Disease (CKD) and an eGFR <15 mL/min/1.73m^2, who can read English and consent to study requirements. Women must use birth control if of child-bearing potential. Excludes those with uncontrolled diabetes (A1C > 10%), cognitive impairments, allergies to potatoes or corn, severe gastrointestinal conditions, severe anemia, recent antibiotic use, or on dialysis.

Inclusion Criteria

In the Investigator's opinion, participant is able and willing to comply with all trial requirements

Participant is willing and able to give informed consent for participation in the trial

Participant has the ability to speak and read English

Exclusion Criteria

Your diabetes is not well controlled, and your hemoglobin A1C level is higher than 10%.

You are allergic to potatoes or corn.

Female participant who is pregnant, lactating or planning pregnancy during the course of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants receive corn starch for acclimatization

2 weeks

1 visit (in-person)

Treatment Period 1

Participants receive either RPS or corn starch based on randomization

6 weeks

2 visits (in-person)

Washout

Participants consume corn starch to clear previous treatment effects

4 weeks

1 visit (in-person)

Treatment Period 2

Participants receive the treatment not previously consumed

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Potato Starch

Trial Overview The trial is testing whether resistant potato starch can reduce uremic toxins by changing gut bacteria in CKD patients compared to standard corn starch. Participants will add this to their usual CKD care regimen to see if it improves symptoms and delays the need for dialysis.

How Is the Trial Designed?

Group I: Resistant Potato Starch Experimental Treatment 1 Intervention

15g RPS mixed with water will be consumed twice per day during intervention

Group II: Corn Starch Placebo Group 1 Intervention

15 g corn starch mixed with water will be consumed twice per day during intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9314005/

Effects of Resistant Starch on Patients with Chronic Kidney ... Some studies have found that the supplementation of RS can improve the intestinal flora disorder in CKD patients. However, the specific effect ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11504232/

Effects of resistant starch supplementation on renal function ... RS supplementation can reduce uremic toxin levels and improve renal function but does not reduce the inflammatory response in patients with CKD.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06009-1

A randomized double-blind cross-over trial to study the effects ... This study aims to investigate the effects of resistant potato starch (RPS) as a prebiotic in individuals with CKD before the onset of dialysis.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04961164

Resistant Starch Prebiotic Effects in Chronic Kidney Disease 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fft2.474

Resistant starch, chronic kidney disease, and the gut ... The review discusses how resistant starch supplementation in CKD patients can shift the gut microbiota composition, promoting short-chain fatty acid-producing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9280786/

The Effects of Resistant Starch Consumption in Adult Patients ... Resistant starch supplementation has shown promising results in altering the microbiota of animal models of chronic kidney disease (CKD).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04961164

Resistant Starch Prebiotic Effects in Chronic Kidney Disease 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 ...