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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Functional Gastrointestinal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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Blueberry

Freeze-dried pure blueberry powder

Group Type ACTIVE_COMPARATOR

Blueberry

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Maltodextrin powder.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

matched powder maltodextrin twice daily = 60kcal

Interventions

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Blueberry

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

matched powder maltodextrin twice daily = 60kcal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No