Status unknownNCT04824976Updated Apr 1, 2021

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

An interventional study of Blueberry and Placebo in Functional Gastrointestinal Disorders, sponsored by Brain-Gut Research Group. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Brain-Gut Research Group · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 55
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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 studied

Functional Gastrointestinal Disorders

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Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 55 participants (estimated)

Study arms

Active comparator
Blueberry
Freeze-dried pure blueberry powder
Dietary Supplement: Blueberry
Placebo comparator
Placebo
Maltodextrin powder.
Dietary Supplement: Placebo

Interventions

Dietary supplementBlueberry
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
Dietary supplementPlacebo
matched powder maltodextrin twice daily = 60kcal

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in cognitive neurological function tests
Cambridge Cognition neurocognitive test battery (CANTAB)
Time frame: before and after 6 weeks of each treatment arm
Change in musculoskeletal symptoms
Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores
Time frame: 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
Time frame: 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
Time frame: before and after 6 weeks of each treatment

Study locations

1 of 1 sites recruiting

Gastroenterology Group Practice / Brain-Gut Research Group
Bern, 3011, Switzerland
- Clive Wilder-Smith, MD · Contact · info@ggp.ch · +41313123737
Recruiting

Registry details

Key details

Study ID: NCT04824976
Lead sponsor: Brain-Gut Research Group
Collaborators: Aalborg University, Maastricht University Medical Center
Responsible party: Clive H Wilder-Smith, MD (Dr, Brain-Gut Research Group) — Principal investigator
First posted: Apr 1, 2021
Start date: Jan 1, 2020
Primary completion: Dec 31, 2021 (estimated)
Completion: Apr 1, 2022 (estimated)
Last update: Apr 1, 2021

Study contacts

Clive Wilder-Smith, MD

Contact

info@braingut.com

+41313123737

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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