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

NCT04824976 | Unknown

• 1 other identifier: BB-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Validated scale of GI symptoms

  before and after 6 weeks of each treatment arm

Secondary Outcomes (4)

• Change in cognitive neurological function tests

  before and after 6 weeks of each treatment arm

• Change in musculoskeletal symptoms

  before and after 6 weeks of each treatment arm

• Change in breath gas concentrations and symptoms scores during fructose breath testing

  before and after 6 weeks of each treatment

• Change in laboratory markers for advanced glycation end products, tight junction proteins

  before and after 6 weeks of each treatment

Study Arms (2)

Blueberry

ACTIVE COMPARATOR

Freeze-dried pure blueberry powder

Dietary Supplement: Blueberry

Placebo

PLACEBO COMPARATOR

Maltodextrin powder.

Dietary Supplement: Placebo

Interventions

Blueberry DIETARY_SUPPLEMENT

freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal

Blueberry

Placebo DIETARY_SUPPLEMENT

matched powder maltodextrin twice daily = 60kcal

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brain-Gut Research Group: lead
• Aalborg University: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

Gastroenterology Group Practice / Brain-Gut Research Group

Bern, 3011, Switzerland

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Clive Wilder-Smith, MD

CONTACT

+41313123737; info@braingut.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 1, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: April 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CH (1)