Clinical trial NCT04824976: Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
Official title: Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Brain-Gut Research Group
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Maastricht University Medical Center
First posted: 2021-04-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: before and after 6 weeks of each treatment arm
Secondary outcomes:
measure: Change in cognitive neurological function tests
timeFrame: before and after 6 weeks of each treatment arm
measure: Change in musculoskeletal symptoms
timeFrame: before and after 6 weeks of each treatment arm
measure: Change in breath gas concentrations and symptoms scores during fructose breath testing
timeFrame: before and after 6 weeks of each treatment
measure: Change in laboratory markers for advanced glycation end products, tight junction proteins
timeFrame: before and after 6 weeks of each treatment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Gastroenterology Group Practice / Brain-Gut Research Group
Study officials:
References: