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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 and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)
The study will have a randomized, double-blind, crossover design with 8 visits consisting of one screening visit and 7 study visits (3 to 14-day interval between the start of each visit) across 4-12 weeks. Participants will be randomized to a test sequence and, during the course of the study, will complete 7 trial arms. At each visit eligible participants will come to INQUIS between 8-11am, and ~1-2h after consuming their usual breakfast at home. After rating the severity of GI symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting. The severity of each symptom will be rated by the subject as None, Mild, Moderate or Severe (these ratings will be assigned scores of 0, 1, 2 or 3, respectively). For each bowel movement (BM) passed during the 24h period, participants will be asked to record: the time, if they had to strain (yes or no), if they experienced discomfort (yes or no), if they felt there was incomplete evacuation (yes or no), if they had oily evacuation (oil separated from the stools) (yes or no), if they had oily stool (oily lumps in the stool) (yes or no) 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 biscuit | Placebo Comparator | Sandwiched biscuit with usual sugar and fat content (2 servings = 60g) |
|
| Control biscuit reduced in fat with EPG | Active Comparator | Sandwiched biscuit with usual sugar content and fat partly replaced by EPG in basecake (2 servings = 60g) |
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| Sugar reduced biscuit with blend 1 | Active Comparator | Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 (2 servings = 60g) |
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| Sugar reduced biscuit with blend 1 + EPG in basecake | Active Comparator | Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake (2 servings = 60g) |
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| Sugar reduced biscuit with blend 1 + EPG in basecake & creme | Active Comparator | Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake & creme (2 servings = 60g) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test sandwiched biscuits with creme | 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 11 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 11 gastrointestinal symptoms (Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting). Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis Clinical Research | Toronto | Ontario | M5C 2N8 | Canada |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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In a 7-way cross-over, 14 sequences are required to obtain a balanced design. Orders will be assigned to participants in the order they attended for the first visit after being recruited. Four of these sequences will be separately randomized to create n=56 random sequences. If more subjects are recruited to replace drop-outs then the first new recruit will be assigned the sequence assigned the first drop-out, the second new recruit to sequence assigned to the second drop-out, etc.
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The products will be labelled with a code, and participants will not be informed which test meal is which. Double 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. After the database has been created, cleaned, and locked a copy will be sent to the sponsor and then the codes will be broken.
| Sugar reduced biscuit with blend 2 | Active Comparator | Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 (2 servings = 60g) |
|
| Sugar reduced biscuit with blend 2 + EPG in basecake | Active Comparator | Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 and EPG replacing fat in basecake (2 servings = 60g) |
|
| Control sandwiched biscuit with sugar | Other | Acute intake |
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| tAUC between 0 and 24 hours |
| 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 for bloating | 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 |
| 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 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 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 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 gas with discharge | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for gas with discharge | 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 gas with discharge | 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 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 reflux | 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 stomach rumbling | 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 Oily spotting (leakage) | Time of the maximum score | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours |
| Maximum score for Evaluation oily spotting (leakage) | 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 oily spotting (leakage) | 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 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 vomiting | 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 |
| 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 |
| oily evacuation (oil separated from the stools) | Proportion of participants declaring having oily evacuation (oil separated from the stools) | Evaluation performed over 24 hour after consumption of study products |
| oily stool (oily lumps in the stool) | Proportion of participants declaring having oily stool (oily lumps in the stool) | 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 |