Resistant Starch for Chronic Kidney Disease

(ReSPECKD Trial)

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if taking Resistant Potato Starch (RPS) can help patients with Chronic Kidney Disease by improving their gut bacteria and reducing harmful blood toxins. A high resistant starch diet has shown to slow down CKD progression and reduce oxidative stress and inflammation in rats.

Research Team

Dylan Mackay, PhD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+