Phase
Condition
N/ATreatment
Resistant Potato Starch, Corn Starch
Corn Starch, Resistant Potato Starch
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is willing and able to give informed consent for participation in thetrial.
Participant has the ability to speak and read English.
Male or Female, aged 18 years or above. Females of child-bearing potential mustagree to use a medically approved method of birth control for the duration of thestudy. All hormonal birth control must have been in use for a minimum of threemonths. Acceptable methods of birth control include: Hormonal contraceptivesincluding oral contraceptives, hormone birth control patch, vaginal contraceptivering, injectable contraceptives, or hormone implant, double-barrier method,intrauterine devices, non-heterosexual lifestyle or agrees to use contraception ifplanning on changing to heterosexual partner(s), vasectomy of partner at least 6months 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 alltrial requirements.
Exclusion
Exclusion Criteria:
The participant is cognitively impaired and cannot give consent or participate inthe group program
The participant has an existing relationship with the research team, such assupervisory 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 thecourse 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 toobtain written informed consent.
Participating in another interventional trial that could influence the interventionor 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 ofthe oesophagus and/or the superior opening of the stomach (cardia), potential orexisting intestinal blockage, paralysis of the intestine, megacolon, faecalimpaction, appendicitis, a sudden change in bowel habits that has persisted for morethan 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the useof 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/adequatefiber intake through diet.
Study Design
Study Description
Connect with a study center
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba R2V 3M3
CanadaSite Not Available
Health Science Centre (HSC)
Winnipeg, Manitoba R3A 1R9
CanadaSite Not Available
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