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This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).
This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design.
Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel alpha glucan_dose1 | Experimental | Total of 180 g of the novel alpha glucan per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) |
|
| Novel alpha glucan_dose2 | Experimental | Total of 80 g of the novel alpha glucan + 100 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) |
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| glucose syrup | Active Comparator | Total of 180 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinkable solution | Dietary Supplement | The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS) | Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment. | Throughout 7 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency | The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools, whereas 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhoea. The effect of the interventions on stool consistency will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab | Lausanne | Canton of Vaud | 1000 Lausanne 26 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19428713 | Result | Kelly RM, Dijkhuizen L, Leemhuis H. Starch and alpha-glucan acting enzymes, modulating their properties by directed evolution. J Biotechnol. 2009 Mar 25;140(3-4):184-93. doi: 10.1016/j.jbiotec.2009.01.020. Epub 2009 Feb 7. | |
| 25332993 | Result | Synytsya A, Novak M. Structural analysis of glucans. Ann Transl Med. 2014 Feb;2(2):17. doi: 10.3978/j.issn.2305-5839.2014.02.07. |
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3x3
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| Throughout 7 days of treatment |
| Stool frequency | The participants report the number of defecations they have per day, throughout the 7 days study period. There is a large variability in this, but typically 1-3 defecations per day is considered normal, whereas more indicate a runny stool, and fewer a tendency for constipation. The effect of the interventions on stool frequency will be assessed by changes in stool frequency over time, taking all information on this from all 7 days of treatment into account. | Throughout 7 days of treatment |