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| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
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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
The study will have a randomized, single-blind, crossover design with 5 visits consisting of one screening visit and 4 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 3 test products made with the sugar replacer blend over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and ~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (Abdominal bloating, Abdominal pain/discomfort, Gas/flatulence, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Nausea and Vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control sugar candies | Placebo Comparator | Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings) |
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| Test low sugar candies dose 1 | Active Comparator | low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings) |
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| Test low sugar candies dose 2 | Active Comparator | 64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) |
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| Test low sugar candies dose 3 | Active Comparator | 82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-sugar candies compared to regular sugar candies | Other | Acute intake |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Frequency of composite score > 1 at each time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas MS Wolever, aMD, PhD | Contact | 416-861-9177 | twolever@inquis.com | |
| Alexandra Meynier, PhD | Contact | +33 (0)1 83 11 45 68 | alexandra.meynier@mdlz.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis Clinical Research | Toronto | Ontario | Canada |
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In a 4-way cross-over, there is a set of 4 balanced sequences to which participants will be randomly assigned (ABCD, BADC, CDAB, DCBA). Blocks of 2, 3, or 4 sets of sequences were randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
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The products will be labelled with a code and participants will not be informed which test meal is which. However, since the portion sizes of some of the treatments differ, some information about them may be available to participants and study coordinators; that is why we have termed the study "single blind". Single blinding will be achieved by identifying the treatments by code on the case report forms and in the database, so that those doing the statistical analysis and the study sponsor will be unaware of the treatment assignments.
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 |
| 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 |
| 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 |
| Number of bowel movements | Number of bowel movements over the 24 hours | Evaluation performed over 24 hour after consumption of study products |
| straining during bowel movement | Proportion of participants having to strain or not | Evaluation performed over 24 hour after consumption of study products |
| discomfort during bowel movement | Proportion of participants having discomfort or not | Evaluation performed over 24 hour after consumption of study products |
| incomplete evacuation | Proportion of participants declaring incomplete evacuation or not | Evaluation performed over 24 hour after consumption of study products |
| 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 |