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| Name | Class |
|---|---|
| BioFortis | OTHER |
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This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1 serving equivalent |
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| Test 2 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 1.75 serving equivalent |
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| Test 3 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + Allulose provided at a dose of 2.5 serving equivalent |
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| Test 4 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1 serving equivalent |
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| Test 5 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 1.75 serving equivalent |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator | Other | One pack of each product (1 to 10) will be consumed on a separate occasion |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control | AUC of the composite Gastrointestinal symptoms score based on GITQ (gastro-intestinal tolerance questionnaire) | AUC between 0 to 48 hours after intake of products |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the continuous AUC of the composite GI symptom score between doses within each formulation | Area under the curve (AUC) of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire) | AUC between 0 to 48 hours after intake of products |
| Difference in the continuous AUC of the composite GI symptom score between formulations within each dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Kelley, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Addison | Illinois | 60101 | United States |
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Each subject will be allocated to a sequence of consumption of the 10 different products
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Products have been produced with different shapes and with very close texture, colors and taste. They are packaged in individual portion bags labeled "Product 1" to "Product 10".
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| Test 6 | Active Comparator | No-sugar chewable candy containing Soluble Corn Fiber + Inulin + FOS provided at a dose of 2.5 serving equivalent |
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| Test 7 | Active Comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1 serving equivalent |
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| Test 8 | Active Comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 1.75 serving equivalent |
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| Test 9 | Active Comparator | No-sugar chewable candy containing Maltitol + Polydextrose provided at a dose of 2.5 serving equivalent |
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| Test 10 | Placebo Comparator | Control chewable candy made with sugar and provided at a dose of 1 serving equivalent |
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AUC of the composite GI symptoms score based on GITQ |
| AUC between 0 to 48 hours after intake of products |
| Difference in the continuous AUC for each individual GI symptom score of test products as compared to control, dose within each formulation, and formulation within each dose | AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire) | AUC between 0 to 48 hours after intake of products |
| Proportion of subjects who have a composite GI symptom score larger than 1 at each measured time point | AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire) | AUC between 0 to 48 hours after intake of products |
| Proportion of subjects with diarrhea based on BHD-BSS (Bowel Habit Diary - Brictol Stool Scale) | diarrhea | Evaluation over 24 hours following intake of products |
| Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) symptom at each measured time point for each individual outcome | Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire) | Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours |
| Summary of the maximum detected score for each individual GI symptom | Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire) | Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours |
| Summary of the time of the maximum detected score for each individual symptom | Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire) | Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours |
| Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) bothersome loose stools on the GITQ at each measured time point | Loose stools from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale) | Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours |
| Difference between test and control products, between dose within each formulation, and between formulation within each dose for all parameters of the BHD-BSS (Bowel Habit Diary - Brictol Stool Scale) | Bowel movment characteristics from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale) | At each bowel movement over 48 hours |
| Urinary allulose | Difference between test and control products, between dose (number of servings) within each formulation, and between formulation within each dose on urinary Allulose | Collect over 24 hours |
| Gut Microbiota composition | Microbial composition by sequencing | Baseline |
| Correlation analyses between microbiota composition and GITQ individual parameters | Mechanism of action | AUC 0 to 48 hours for composite scores and evaluations performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours |