- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04824976
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Clive Wilder-Smith, MD
- Phone Number: +41313123737
- Email: info@braingut.com
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.
Sponsor
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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