Functional Gastrointestinal Disorders
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBlueberry
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
DIETARY_SUPPLEMENTPlacebo
matched powder maltodextrin twice daily = 60kcal
Sponsors
Aalborg University
Maastricht University Medical Center
Brain-Gut Research Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Fifty-five successive male or female patients with Functional Gastrointestinal Disorders FGID) enrolled from our Gastroenterology Group Practice (GGP) in Bern, Switzerland, classified as having either Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or both according to Rome 4 criteria (Drossman et al 2016; Schmulson et al. 2017) * Age between 18 and 50 years * Body mass index 18.5-29.9 kg/m2 * European / Caucasian ethnicity * Able to give informed consent in German as documented by signature
Exclusion criteria
* Evidence of clinically significant disease, as assessed by usual clinical practice (history, blood and stool tests, imaging and endoscopy, as clinically required) and by investigator. * Colonoscopy, antibiotics or probiotics within 2 weeks before or during the study. * Planned dietary modifications (including polyphenol-rich fruit or vegetable smoothies, drinks or diets) or initiation of new treatments during the study period, besides the study interventions. * Inability or contraindications to undergo the investigated intervention * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | before and after 6 weeks of each treatment arm | Validated scale of GI symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive neurological function tests | before and after 6 weeks of each treatment arm | Cambridge Cognition neurocognitive test battery (CANTAB) |
| Change in musculoskeletal symptoms | before and after 6 weeks of each treatment arm | Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores |
| Change in breath gas concentrations and symptoms scores during fructose breath testing | before and after 6 weeks of each treatment | AUCs (areas under curve) of hydrogen, methane and symptom scores during fructose breath tests |
| Change in laboratory markers for advanced glycation end products, tight junction proteins | before and after 6 weeks of each treatment | Validated biochemical markers of advanced glycation, tight junction protein quantification |
Countries
Switzerland
Contacts
Primary ContactClive Wilder-Smith, MD
Outcome results
None listed