- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961164
Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca Mollard, PhD
- Phone Number: 204-631-3834
- Email: rmollard@sogh.mb.ca
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Recruiting
- Health Science Centre (HSC)
-
Principal Investigator:
- Dylan Mackay, PhD
-
Contact:
- Maryam Samsamikor, PhD
- Phone Number: (204) 632-3663
- Email: Maryam.samsamikor@umanitoba.ca
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Winnipeg, Manitoba, Canada, R2V 3M3
- Completed
- Chronic Disease Innovation Centre, Seven Oaks Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistant Potato Starch
15g RPS mixed with water will be consumed twice per day during intervention
|
Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
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Placebo Comparator: Corn Starch
15 g corn starch mixed with water will be consumed twice per day during intervention
|
Consume corn starch at study period 1, then consume resistant starch at study period 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood uremic toxin, indoxyl sulphate, between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
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
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Change in p-cresyl sulphate concentrations in serum
|
between endpoints of each experimental period (week 8 to week 18)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms score using the Edmonton Symptom Assessment Scale between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
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)
|
Change in quality of life of participants between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
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)
|
Change in alpha diversity of the gut microbiome between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
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)
|
Change in beta diversity of the gut microbiome between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in differential abundance in the gut microbiome between treatments
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package
|
between endpoints of each experimental period (week 8 to week 18)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in waist circumference
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Waist circumference will be measured in cm.
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in body weight
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Body weight will be measured in kg
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in serum glucose
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
glucose in mmol/L
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in Hemoglobin A1c
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Hemoglobin A1c as percentage
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in urinary total protein
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Total protein in mg/dL
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in urinary glucose concentration
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
Glucose in mmol/L
|
between endpoints of each experimental period (week 8 to week 18)
|
Change in urinary albumin/creatinine ratio
Time Frame: between endpoints of each experimental period (week 8 to week 18)
|
albumin concentration in milligrams divided by creatinine concentration in grams
|
between endpoints of each experimental period (week 8 to week 18)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dylan Mackay, PhD, University of Manitoba
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS23161 (B2019:089)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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