Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders

Not Applicable

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Blueberry

• Registration Number: NCT04824976
• Lead Sponsor: Brain-Gut Research Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-31
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin powder.
Blueberry	Blueberry	Freeze-dried pure blueberry powder

Primary Outcome Measures

Name	Time	Method
Change in Gastrointestinal Symptom Rating Scale (GSRS)	before and after 6 weeks of each treatment arm	Validated scale of GI symptoms

Secondary Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Gastroenterology Group Practice / Brain-Gut Research Group; 🇨🇭 Bern, Switzerland