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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824976
• Other study ID #: BB-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2021
• Source: Brain-Gut Research Group
• Contact: Clive Wilder-Smith, MD
• Phone: +41313123737
• Email: info[@]braingut.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Blueberry
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
• Placebo
matched powder maltodextrin twice daily = 60kcal

Locations

Country	Name	City	State
Switzerland	Gastroenterology Group Practice / Brain-Gut Research Group	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Brain-Gut Research Group	Aalborg University, Maastricht University Medical Center

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gastrointestinal Symptom Rating Scale (GSRS)	Validated scale of GI symptoms	before and after 6 weeks of each treatment arm
Secondary	Change in cognitive neurological function tests	Cambridge Cognition neurocognitive test battery (CANTAB)	before and after 6 weeks of each treatment arm
Secondary	Change in musculoskeletal symptoms	Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores	before and after 6 weeks of each treatment arm
Secondary	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
Secondary	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