Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Toleranc… (NCT06479330) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
Canada60 participantsStarted 2024-07-09
Plain-language summary
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)
Who can participate
Age range18 Years – 55 Years
SexALL
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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:
* 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…
What they're measuring
1
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score