Resistant Starch Prebiotic Effects in Chronic Kidney Disease

NCT04961164 | Completed

• 1 other identifier: HS23161 (B2019:089)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; Resistant Potato Starch; uremic toxins (indoxyl sulphate, p-cresyl sulphate); gut microbiota; metabolomics

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• Change in symptoms score using the Edmonton Symptom Assessment Scale between treatments

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

• Change in quality of life of participants between treatments

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

• Change in alpha diversity of the gut microbiome between treatments

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

• Change in beta diversity of the gut microbiome between treatments

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

• Change in differential abundance in the gut microbiome between treatments

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

Other Outcomes (7)

• Change in waist circumference

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

• Change in body weight

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

• Change in serum glucose

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

Study Arms (2)

Resistant Potato Starch

EXPERIMENTAL

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

Dietary Supplement: Resistant Potato Starch, Corn Starch

Corn Starch

PLACEBO COMPARATOR

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

Dietary Supplement: Corn Starch, Resistant Potato Starch

Interventions

Resistant Potato Starch, Corn Starch DIETARY_SUPPLEMENT

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

Resistant Potato Starch

Corn Starch, Resistant Potato Starch DIETARY_SUPPLEMENT

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

Corn Starch

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Health Science Centre (HSC)

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (1)

• 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.

  PMID: 35073986 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Starch

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Dylan Mackay, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: July 14, 2021
• Study Start: September 27, 2022
• Primary Completion: November 20, 2024
• Study Completion: November 30, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

CA (2)