Resistant Starch Prebiotic Effects in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— ReSPECKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961164
• Other study ID #: HS23161 (B2019:089)
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: University of Manitoba
• Contact: Rebecca Mollard, PhD
• Phone: 204-631-3834
• Email: rmollard[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Resistant Potato Starch, Corn Starch
Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
• Corn Starch, Resistant Potato Starch
Consume corn starch at study period 1, then consume resistant starch at study period 2.

Locations

Country	Name	City	State
Canada	Chronic Disease Innovation Centre, Seven Oaks Hospital	Winnipeg	Manitoba
Canada	Health Science Centre (HSC)	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in waist circumference	Waist circumference will be measured in cm.	between endpoints of each experimental period (week 8 to week 18)
Other	Change in body weight	Body weight will be measured in kg	between endpoints of each experimental period (week 8 to week 18)
Other	Change in serum glucose	glucose in mmol/L	between endpoints of each experimental period (week 8 to week 18)
Other	Change in Hemoglobin A1c	Hemoglobin A1c as percentage	between endpoints of each experimental period (week 8 to week 18)
Other	Change in urinary total protein	Total protein in mg/dL	between endpoints of each experimental period (week 8 to week 18)
Other	Change in urinary glucose concentration	Glucose in mmol/L	between endpoints of each experimental period (week 8 to week 18)
Other	Change in urinary albumin/creatinine ratio	albumin concentration in milligrams divided by creatinine concentration in grams	between endpoints of each experimental period (week 8 to week 18)
Primary	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)
Primary	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	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.	between endpoints of each experimental period (week 8 to week 18)
Secondary	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.	between endpoints of each experimental period (week 8 to week 18)
Secondary	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	between endpoints of each experimental period (week 8 to week 18)
Secondary	Change in beta diversity of the gut microbiome between treatments	Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples	between endpoints of each experimental period (week 8 to week 18)
Secondary	Change in differential abundance in the gut microbiome between treatments	Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package	between endpoints of each experimental period (week 8 to week 18)