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Chronic Kidney DiseasesReSPECKDNCT04961164

Resistant Starch Prebiotic Effects in Chronic Kidney Disease

A study testing Resistant Potato Starch, Corn Starch and Corn Starch, Resistant Potato Starch in people with Chronic Kidney Diseases, run by University of Manitoba at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Resistant Potato Starch, Corn Starch and Corn Starch, Resistant Potato Starch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesCanada
Study dates
27 Sep 2022to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the trial.
  • Participant has the ability to speak and read English.
  • Male or Female, aged 18 years or above. Females of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening.
  • Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m^2 for the past 3 months
  • In the Investigator's opinion, participant is able and willing to comply with all trial requirements.

Who cannot join

  • The participant is cognitively impaired and cannot give consent or participate in the group program
  • The participant has an existing relationship with the research team, such as supervisory relationship (student, employee) or familial relationship (child, spouse, etc)
  • Participants who indicate that they cannot consume study treatments.
  • Participants who indicates they are allergic to potatoes or corn
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  • History of renal transplant, ongoing dialysis, use of antibiotics (last 3-months), bowel diseases, cancer, surgically removed bowel, or any gastrointestinal surgery (e.g. intestinal resection, gastric bypass, colorectal surgery)
Show all 14Show fewer
  • Inability to consume treatment due to swallowing or GI issues and inability to obtain written informed consent.
  • Participating in another interventional trial that could influence the intervention or outcome of this trial.
  • Participants with uncontrolled diabetes with a hemoglobin A1C > 10%.
  • Participants who consume probiotic supplements.
  • Participants with abnormal constrictions of the gastrointestinal tract, diseases of the oesophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, faecal impaction, appendicitis, a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative prod.
  • Participants with severe anemia (hemoglobin less than 70).
  • Participants taking medications which inhibit peristaltic movement (e.g. opioids,loperamide).
  • Participants taking other fiber supplements or able to maintain high fiber/adequate fiber intake through diet.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Chronic Disease Innovation Centre, Seven Oaks Hospital

    Winnipeg, Manitoba, R2V 3M3

  • Health Science Centre (HSC)

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)

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.

Read the detailed description

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.

Being tested
Resistant Potato Starch, Corn Starch, Corn Starch, Resistant Potato Starch
Keywords
Chronic Kidney Disease, Resistant Potato Starch, uremic toxins (indoxyl sulphate, p-cresyl sulphate), gut microbiota, metabolomics
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistant Potato Starch, Corn StarchDietary supplement

    Consume resistant potato starch at study period 1, then consume corn starch at study period 2.

  • Corn Starch, Resistant Potato StarchDietary supplement

    Consume corn starch at study period 1, then consume resistant starch at study period 2.

Study groups in NCT04961164
Study groupRoleWhat they receive
Resistant Potato StarchExperimental15g RPS mixed with water will be consumed twice per day during intervention
Receives: Dietary Supplement: Resistant Potato Starch, Corn Starch
Corn StarchPlacebo comparator15 g corn starch mixed with water will be consumed twice per day during intervention
Receives: Dietary Supplement: Corn Starch, Resistant Potato Starch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood uremic toxin, indoxyl sulphate, between treatments

    Change in indoxyl sulphate concentrations in serum

    Measured: between endpoints of each experimental period (week 8 to week 18)

  2. Change in blood uremic toxin, p-cresyl sulphate, between treatments

    Change in p-cresyl sulphate concentrations in serum

    Measured: between endpoints of each experimental period (week 8 to week 18)

Secondary outcomes (5)

  1. 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.

    Measured: between endpoints of each experimental period (week 8 to week 18)

  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.

    Measured: between endpoints of each experimental period (week 8 to week 18)

  3. 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

    Measured: between endpoints of each experimental period (week 8 to week 18)

  4. Change in beta diversity of the gut microbiome between treatments

    Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples

    Measured: between endpoints of each experimental period (week 8 to week 18)

  5. Change in differential abundance in the gut microbiome between treatments

    Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package

    Measured: between endpoints of each experimental period (week 8 to week 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start27 Sep 2022
  3. Primary completion20 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961164
Sponsor's protocol ID
HS23161 (B2019:089)
Acronym
ReSPECKD
Status last verified
Mar 2025
First submitted
26 Oct 2020
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35073986

Questions about this trial

What is this clinical trial studying?

A study testing Resistant Potato Starch, Corn Starch and Corn Starch, Resistant Potato Starch in people with Chronic Kidney Diseases, run by University of Manitoba at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood uremic toxin, indoxyl sulphate, between treatments (time frame: between endpoints of each experimental period (week 8 to week 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04961164, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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