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| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
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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)
The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 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 4 test products made with the sugar replacer ingredients or blend of ingredients 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, 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 Bristol Stool Scale (BSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control chocolate with sugar | Placebo Comparator | Milk chocolate made with sugar at a dose of 45 g (2 servings) |
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| Maltitol chocolate | Active Comparator | Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings) |
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| Kestose chocolate | Active Comparator | Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings) |
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| Kestose + cocoa and polydextrose premix dose 1 chocolate | Active Comparator | Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings) |
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| Kestose + cocoa and polydextrose premix dose 2 chocolate | Active Comparator | Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk Chocolate | 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 (abdominal bloating, abdominal pain, flatulence, burping, reflux, stomach rumbling, nausea, vomiting). Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms | tAUC between 0 and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis Clinical Research | Toronto | Ontario | Canada |
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In a 5-way cross-over, there is a set of 10 balanced sequences to which participants will be randomly assigned. Blocks of 1 or 2 sets of sequences will be 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 so study staff and research participants will be blinded as to which test meal is which. After the database will be cleaned and locked, and statistical analysis will be completed, and the codes will be broken.
| 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 |
| 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 |
| Time for maximum score for abdominal bloating | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for abdominal bloating | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for abdominal bloating | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for abdominal pain | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for abdominal pain | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time of maximum score for abdominal pain | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for flatulence | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for flatulence | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for flatulence | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for burping | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for burping | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for burping | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for reflux | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for reflux | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for reflux | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for stomach rumbling | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for stomach rumbling | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for stomach rumbling | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for nausea | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for nausea | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for nausea | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for vomiting | Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for vomiting | Maximum detected score (which can range from 0 up to 3) | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Time for maximum score for vomiting | 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 bristol 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 |