Resistant Potato Starch, Corn Starch
Dietary SupplementConsume resistant potato starch at study period 1, then consume corn starch at study period 2.
NCT Number: NCT04961164
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consume resistant potato starch at study period 1, then consume corn starch at study period 2.
Consume corn starch at study period 1, then consume resistant starch at study period 2.
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in indoxyl sulphate concentrations in serum
Time frame: between endpoints of each experimental period (week 8 to week 18)
Change in p-cresyl sulphate concentrations in serum
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.
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.
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
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
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
Time frame: between endpoints of each experimental period (week 8 to week 18)
Waist circumference will be measured in cm.
Time frame: between endpoints of each experimental period (week 8 to week 18)
Body weight will be measured in kg
Time frame: between endpoints of each experimental period (week 8 to week 18)
glucose in mmol/L
Time frame: between endpoints of each experimental period (week 8 to week 18)
Hemoglobin A1c as percentage
Time frame: between endpoints of each experimental period (week 8 to week 18)
Total protein in mg/dL
Time frame: between endpoints of each experimental period (week 8 to week 18)
Glucose in mmol/L
Time frame: between endpoints of each experimental period (week 8 to week 18)
albumin concentration in milligrams divided by creatinine concentration in grams
University of Manitoba
Other
A Randomized Double-Blind Cross-over Trial to Study the Effects of Resistant Starch Prebiotic Effects in Chronic Kidney Disease (ReSPECKD)
Acronym: ReSPECKD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03386539
Behavior, Cardiac Allograft Vasculopathy
Birmingham, Alabama, United States
View Trial DetailsNCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT06071143
Chronic Disease, Chronic Kidney Diseases
Daejeon, Chungcheongnam-do, South Korea
View Trial DetailsNCT05033652
Acute Kidney Injury, Chronic Disease
Alès, France
View Trial Details