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Resistant Starch for Chronic Kidney Disease (ReSPECKD Trial)

N/A
Recruiting
Led By Dylan Mackay, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between endpoints of each experimental period (week 8 to week 18)
Awards & highlights

ReSPECKD Trial Summary

This trial will test whether resistant potato starch can help reduce symptoms in patients with Chronic Kidney Disease by altering the gut microbiota.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive issues like bloating or gas due to increased fiber intake from the resistant potato starch. Allergic reactions are possible but only in those with known allergies to potatoes or corn.

ReSPECKD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between endpoints of each experimental period (week 8 to week 18)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between endpoints of each experimental period (week 8 to week 18) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood uremic toxin, indoxyl sulphate, between treatments
Change in blood uremic toxin, p-cresyl sulphate, between treatments
Secondary outcome measures
Change in alpha diversity of the gut microbiome between treatments
Change in beta diversity of the gut microbiome between treatments
Change in differential abundance in the gut microbiome between treatments
+2 more
Other outcome measures
Change in Hemoglobin A1c
Change in body weight
Change in serum glucose
+4 more

ReSPECKD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Resistant Potato StarchExperimental Treatment1 Intervention
15g RPS mixed with water will be consumed twice per day during intervention
Group II: Corn StarchPlacebo Group1 Intervention
15 g corn starch mixed with water will be consumed twice per day during intervention

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,470 Total Patients Enrolled
Dylan Mackay, PhDPrincipal InvestigatorUniversity of Manitoba
5 Previous Clinical Trials
205 Total Patients Enrolled

Media Library

Chronic Kidney Disease Research Study Groups: Resistant Potato Starch, Corn Starch
Chronic Kidney Disease Clinical Trial 2023: Resistant Potato Starch, Corn Starch Highlights & Side Effects. Trial Name: NCT04961164 — N/A
Resistant Potato Starch, Corn Starch 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961164 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research project still occurring?

"Per the information reported on clinicaltrials.gov, this trial is actively sourcing participants. Initially posted in September 2022, it was last updated at the same time."

Answered by AI

How many participants have registered for the trial thus far?

"Affirmative. As per the data on clinicaltrials.gov, this trial is actively recruiting participants since September 27th 2022 - when it was initially listed - and has been updated as of that same date. 36 patients are required from 1 medical centre for enrollment into the study."

Answered by AI

What impact is this research hoping to make?

"During the experimental period (between weeks 12 and 26), this medical trial will measure changes in blood uremic toxin levels, Edmonton Symptom Assessment Scale scores, identified Operational Taxonomic Units of gut microbiome populations, and Medical Outcomes Study Short Form 36-item questionnaire results. These latter two assessments are used to monitor participant health status with higher values indicating better well-being."

Answered by AI

What criteria must participants satisfy in order to be accepted into this research project?

"This research is seeking 36 individuals with chronic kidney disease (CKD) between 18 and 85 years old. To participate, candidates must have had an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m^2 for the past 3 months and be able to comply with all trial requirements as determined by their doctor."

Answered by AI

Is eligibility for this trial restricted to any particular age group?

"This clinical experiment's eligibility criteria necessitates that participants are between 18 and 85 years old. There are also 43 studies for minors, as well as 458 for senior citizens."

Answered by AI
~3 spots leftby May 2024