Functional Gastrointestinal DisordersNCT04824976
Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
A study testing Blueberry in people with Functional Gastrointestinal Disorders, run by Brain-Gut Research Group at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Blueberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Gastroenterology Group Practice / Brain-Gut Research Group
Bern, 3011
Clive Wilder-Smith, MD, +41313123737, info@ggp.ch
About this study
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
- Being tested
- Blueberry, Placebo
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberryDietary supplement
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
PlaceboDietary supplement
matched powder maltodextrin twice daily = 60kcal
| Study group | Role | What they receive |
|---|---|---|
| Blueberry | Active comparator | Freeze-dried pure blueberry powder Receives: Dietary Supplement: Blueberry |
| Placebo | Placebo comparator | Maltodextrin powder. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Validated scale of GI symptoms
Measured: before and after 6 weeks of each treatment arm
Secondary outcomes (4)
Change in cognitive neurological function tests
Cambridge Cognition neurocognitive test battery (CANTAB)
Measured: before and after 6 weeks of each treatment arm
Change in musculoskeletal symptoms
Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores
Measured: before and after 6 weeks of each treatment arm
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
Measured: before and after 6 weeks of each treatment
Change in laboratory markers for advanced glycation end products, tight junction proteins
Validated biochemical markers of advanced glycation, tight junction protein quantification
Measured: before and after 6 weeks of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Maastricht University Medical Center
- Responsible party
- Principal investigator, Clive H Wilder-Smith, MD, Brain-Gut Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824976
- Sponsor's protocol ID
- BB-01
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT04824976
- Acronym / sponsor ID
- BB-01
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Collaborators
- Aalborg University, Maastricht University Medical Center
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry | Active comparator | Dietary Supplement: BlueberryFreeze-dried pure blueberry powder |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin powder. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberryfreeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal | Dietary supplement | Blueberry |
| Placebomatched powder maltodextrin twice daily = 60kcal | Dietary supplement | Placebo |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: before and after 6 weeks of each treatment arm
Validated scale of GI symptoms
4 secondary outcomes
Change in cognitive neurological function tests
Time frame: before and after 6 weeks of each treatment arm
Change in musculoskeletal symptoms
Time frame: 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
Change in laboratory markers for advanced glycation end products, tight junction proteins
Time frame: before and after 6 weeks of each treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry in people with Functional Gastrointestinal Disorders, run by Brain-Gut Research Group at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clive Wilder-Smith, MD (+41313123737, info@braingut.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Rating Scale (GSRS) (time frame: before and after 6 weeks of each treatment arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.