Gastrointestinal Tolerance Clinical Trial
Official title:
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies
This study is a randomized, single-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of a sugar replacer blend (inulin + soluble corn fiber + erythritol) at 3 different doses
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 27, 2024 |
Est. primary completion date | December 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive - BMI 18.5-32.0kg/m², inclusive - No major illness, trauma or surgery requiring hospitalization within 3mo 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/d 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/d of fruits and vegetables combined and =3 (women) or =4 (men) servings/d 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 - 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 during the experimental period - Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements) - Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator - Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines - Known intolerance, sensitivity, or allergy to any ingredients in the study test products - Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification |
Country | Name | City | State |
---|---|---|---|
Canada | Inquis Clinical Research | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mondelez International, Inc. | INQUIS Clinical Research |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score | total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions). | tAUC between 0 and 24 hours | |
Secondary | Total Area Under the Curve of each individual gastrointestinal symptom | Total Area Under the Curve of each of the individual 8 gastrointestinal symptoms. Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms | tAUC between 0 and 24 hours | |
Secondary | Frequency of composite score > 1 at each time point | Proportion of participants who have a composite GastoInestinal symptom score >1 (moderate-to-severe) at each time point. The composite score can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions). | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | |
Secondary | Frequency of Diarrhea within 24 hours | Proportion of participants with diarrhea, defined as 3 or more type 6 or 7 stools (based on the BSS) within the 24 hour period after consumption of the study products | Evaluation performed over 24 hour after consumption of study products | |
Secondary | Maximum score and time for maximum score for each gastrointestinal symptom | For each individual GI symptom: the proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point, the maximum detected score (which can range from 0 up to 3) and the time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | |
Secondary | Number of bowel movements | Number of bowel movements over the 24 hours | Evaluation performed over 24 hour after consumption of study products | |
Secondary | straining during bowel movement | Proportion of participants having to strain or not | Evaluation performed over 24 hour after consumption of study products | |
Secondary | discomfort during bowel movement | Proportion of participants having discomfort or not | Evaluation performed over 24 hour after consumption of study products | |
Secondary | incomplete evacuation | Proportion of participants declaring incomplete evacuation or not | Evaluation performed over 24 hour after consumption of study products | |
Secondary | Stool consistency based on britol stool scale | mean stool consistency on Bristol Stool Scale (BSS). The scale provide values from 1 to 7 depending on the type of stool with 1 being the driest stools and 7 the most liquid one. | Evaluation performed over 24 hour after consumption of study products |
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