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| Name | Class |
|---|---|
| Aalborg University | OTHER |
| Maastricht University Medical Center | OTHER |
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There is extensive pre-clinical evidence for potential health effects of blueberries. These are related, but not exclusively due to their high polyphenol content. This translational, clinical, randomized, cross-over, double-blind, placebo-controlled study will investigate the effects of blueberries in freeze-dried powder form on gastrointestinal and extra-gastrointestinal symptoms and function, as well as specific potential underlying mechanisms, in patients with the overlapping functional gastrointestinal disorders, irritable bowel syndrome and functional dyspepsia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry | Active Comparator | Freeze-dried pure blueberry powder |
|
| Placebo | Placebo Comparator | Maltodextrin powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry | Dietary Supplement | freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | Validated scale of GI symptoms | before and after 6 weeks of each treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive neurological function tests | Cambridge Cognition neurocognitive test battery (CANTAB) | before and after 6 weeks of each treatment arm |
| Change in musculoskeletal symptoms | Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clive Wilder-Smith, MD | Contact | +41313123737 | info@braingut.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Group Practice / Brain-Gut Research Group | Recruiting | Bern | 3011 | Switzerland |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000721609 | blueberry extract |
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Double-blind
| Placebo | Dietary Supplement | matched powder maltodextrin twice daily = 60kcal |
|
| before and after 6 weeks of each treatment arm |
| Change in breath gas concentrations and symptoms scores during fructose breath testing | AUCs (areas under curve) of hydrogen, methane and symptom scores during fructose breath tests | before and after 6 weeks of each treatment |
| Change in laboratory markers for advanced glycation end products, tight junction proteins | Validated biochemical markers of advanced glycation, tight junction protein quantification | before and after 6 weeks of each treatment |