Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistant Potato Starch, Corn Starch
Corn Starch, Resistant Potato Starch
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease, Resistant Potato Starch, uremic toxins (indoxyl sulphate, p-cresyl sulphate), gut microbiota, metabolomics
Eligibility Criteria
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.
Sites / Locations
- Chronic Disease Innovation Centre, Seven Oaks HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Resistant Potato Starch
Corn Starch
Arm Description
15g RPS mixed with water will be consumed twice per day during intervention
15 g corn starch mixed with water will be consumed twice per day during intervention
Outcomes
Primary Outcome Measures
Change in blood uremic toxin, indoxyl sulphate, between treatments
Change in indoxyl sulphate concentrations in serum
Change in blood uremic toxin, p-cresyl sulphate, between treatments
Change in p-cresyl sulphate concentrations in serum
Secondary Outcome Measures
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.
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.
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
Change in beta diversity of the gut microbiome between treatments
Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples
Change in differential abundance in the gut microbiome between treatments
Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package
Full Information
NCT ID
NCT04961164
First Posted
October 26, 2020
Last Updated
August 18, 2023
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT04961164
Brief Title
Resistant Starch Prebiotic Effects in Chronic Kidney Disease
Acronym
ReSPECKD
Official Title
A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Chronic Kidney Disease, Resistant Potato Starch, uremic toxins (indoxyl sulphate, p-cresyl sulphate), gut microbiota, metabolomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistant Potato Starch
Arm Type
Experimental
Arm Description
15g RPS mixed with water will be consumed twice per day during intervention
Arm Title
Corn Starch
Arm Type
Placebo Comparator
Arm Description
15 g corn starch mixed with water will be consumed twice per day during intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant Potato Starch, Corn Starch
Intervention Description
Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn Starch, Resistant Potato Starch
Intervention Description
Consume corn starch at study period 1, then consume resistant starch at study period 2.
Primary Outcome Measure Information:
Title
Change in blood uremic toxin, indoxyl sulphate, between treatments
Description
Change in indoxyl sulphate concentrations in serum
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in blood uremic toxin, p-cresyl sulphate, between treatments
Description
Change in p-cresyl sulphate concentrations in serum
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Secondary Outcome Measure Information:
Title
Change in symptoms score using the Edmonton Symptom Assessment Scale between treatments
Description
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.
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in quality of life of participants between treatments
Description
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.
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in alpha diversity of the gut microbiome between treatments
Description
Shannon index will be computed to measure of richness and evenness of the Operational Taxonomic Units in each sample
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in beta diversity of the gut microbiome between treatments
Description
Bray-Curtis dissimilarity will be computed to measure microbiome composition similarity among samples
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in differential abundance in the gut microbiome between treatments
Description
Identified Operational Taxonomic Units will be tested for differential abundance using DESeq2 package
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Other Pre-specified Outcome Measures:
Title
Change in waist circumference
Description
Waist circumference will be measured in cm.
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in body weight
Description
Body weight will be measured in kg
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in serum glucose
Description
glucose in mmol/L
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in Hemoglobin A1c
Description
Hemoglobin A1c as percentage
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in urinary total protein
Description
Total protein in mg/dL
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in urinary glucose concentration
Description
Glucose in mmol/L
Time Frame
between endpoints of each experimental period (week 8 to week 18)
Title
Change in urinary albumin/creatinine ratio
Description
albumin concentration in milligrams divided by creatinine concentration in grams
Time Frame
between endpoints of each experimental period (week 8 to week 18)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Mollard, PhD
Phone
204-631-3834
Email
rmollard@sogh.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dylan Mackay, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chronic Disease Innovation Centre, Seven Oaks Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 3M3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Mollard, PhD
Phone
204-631-3834
Email
rmollard@sogh.mb.ca
First Name & Middle Initial & Last Name & Degree
Michelle Dinella
Phone
204-632-3383
First Name & Middle Initial & Last Name & Degree
Dylan MacKay, PhD
First Name & Middle Initial & Last Name & Degree
Navdeep Tangri, MD, PHD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35073986
Citation
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.
Results Reference
derived
Learn more about this trial
Resistant Starch Prebiotic Effects in Chronic Kidney Disease
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