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

March 29, 2021 updated by: Clive H Wilder-Smith, MD, Brain-Gut Research Group
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bern, Switzerland, 3011
        • Recruiting
        • Gastroenterology Group Practice / Brain-Gut Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blueberry
Freeze-dried pure blueberry powder
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
Placebo Comparator: Placebo
Maltodextrin powder.
matched powder maltodextrin twice daily = 60kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: before and after 6 weeks of each treatment arm
Validated scale of GI symptoms
before and after 6 weeks of each treatment arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive neurological function tests
Time Frame: before and after 6 weeks of each treatment arm
Cambridge Cognition neurocognitive test battery (CANTAB)
before and after 6 weeks of each treatment arm
Change in musculoskeletal symptoms
Time Frame: before and after 6 weeks of each treatment arm
Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores
before and after 6 weeks of each treatment arm
Change in breath gas concentrations and symptoms scores during fructose breath testing
Time Frame: before and after 6 weeks of each treatment
AUCs (areas under curve) of hydrogen, methane and symptom scores during fructose breath tests
before and after 6 weeks of each treatment
Change in laboratory markers for advanced glycation end products, tight junction proteins
Time Frame: before and after 6 weeks of each treatment
Validated biochemical markers of advanced glycation, tight junction protein quantification
before and after 6 weeks of each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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