Effect of Tapioca-based FiberSMART® Compared to a Glucose Challenge or Water Control on Postprand… (NCT07075822) | Clinical Trial Compass
CompletedNot Applicable
Effect of Tapioca-based FiberSMART® Compared to a Glucose Challenge or Water Control on Postprandial Glycemia in Healthy Subjects: An Acute Randomized Controlled Trial
Canada15 participantsStarted 2025-06-11
Plain-language summary
The goal of this clinical trial is to learn whether a novel tapioca-based soluble fiber, FiberSMART®, affects blood glucose levels after consumption in healthy adult volunteers.
The main questions it aims to answer are:
Does FiberSMART® raise postprandial (after-meal) blood glucose levels? Is the blood glucose response to FiberSMART® different from that of dextrose or water?
Researchers will compare participants' blood glucose responses after consuming 20g of FiberSMART® to their responses after consuming 20g of dextrose or a water control to see if FiberSMART® results in a lower postprandial glucose rise than the dextrose challenge and is no different from the water challenge. Demonstrating the FiberSMART acts like a dietary fiber.
Participants will:
Visit the clinic on three separate mornings after an overnight fast Consume either 20g of FiberSMART® or 20g of dextrose or a water control Undergo 8 finger-prick blood tests over 2 hours to measure blood glucose levels
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects are healthy adult males and non-pregnant females. Subjects must be eligible to receive income in Canada. Family members of staff and/or staff that have no responsibilities/tasks on this particular trial may be subjects
Exclusion Criteria:
* age less than 18 years;
* any known food allergies or intolerances to the investigational product;
* medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable;
* known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions;
* any major medical or surgical events requiring hospitalization within the preceding 3 months;
* the presence of disease or drug(s) which influence digestion and absorption of nutrients;
* the short-term use of systemic steroids or atypical antipsychotics (\<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution)
* any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results;
* any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.