Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits (NCT07372482) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits
Canada56 participantsStarted 2025-10-28
Plain-language summary
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
* Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
* No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
* Ability to understand the study procedures and willing to provide informed consent to participate in the study
* Non-smokers or smokers who smoke \<10 cigarettes/day and are willing not to change nicotine habits during the study period
* Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard drinks/week during the study period
* Willing to refrain from any marijuana or hemp products during the study period
* Normal bowel habits (\>2 bowel movements/week and \<3 bowel movements per day)
* Consumes ≤4 servings/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day of whole grains using the definitions of "serving" .
* Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data
* Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP (Ontario Health Insurance Plan)
* Participants are willing to follow current COVID guidelines with respect to attending study visits
Exclusion Criteria:
* Failure to meet any one of the inclusion criteria
* Chronic moderate to severe gastrointestinal symptoms
* Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and dur…
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.
What they're measuring
1
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score