search
Back to results

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

Primary Purpose

Functional Gastrointestinal Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Blueberry
Placebo
Sponsored by
Brain-Gut Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastroenterology Group Practice / Brain-Gut Research GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Blueberry

Placebo

Arm Description

Freeze-dried pure blueberry powder

Maltodextrin powder.

Outcomes

Primary Outcome Measures

Change in Gastrointestinal Symptom Rating Scale (GSRS)
Validated scale of GI symptoms

Secondary Outcome Measures

Change in cognitive neurological function tests
Cambridge Cognition neurocognitive test battery (CANTAB)
Change in musculoskeletal symptoms
Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores
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
Change in laboratory markers for advanced glycation end products, tight junction proteins
Validated biochemical markers of advanced glycation, tight junction protein quantification

Full Information

First Posted
March 31, 2020
Last Updated
March 29, 2021
Sponsor
Brain-Gut Research Group
Collaborators
Aalborg University, Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04824976
Brief Title
Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
Official Title
Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brain-Gut Research Group
Collaborators
Aalborg University, Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blueberry
Arm Type
Active Comparator
Arm Description
Freeze-dried pure blueberry powder
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry
Intervention Description
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
matched powder maltodextrin twice daily = 60kcal
Primary Outcome Measure Information:
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Description
Validated scale of GI symptoms
Time Frame
before and after 6 weeks of each treatment arm
Secondary Outcome Measure Information:
Title
Change in cognitive neurological function tests
Description
Cambridge Cognition neurocognitive test battery (CANTAB)
Time Frame
before and after 6 weeks of each treatment arm
Title
Change in musculoskeletal symptoms
Description
Validated Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) scores
Time Frame
before and after 6 weeks of each treatment arm
Title
Change in breath gas concentrations and symptoms scores during fructose breath testing
Description
AUCs (areas under curve) of hydrogen, methane and symptom scores during fructose breath tests
Time Frame
before and after 6 weeks of each treatment
Title
Change in laboratory markers for advanced glycation end products, tight junction proteins
Description
Validated biochemical markers of advanced glycation, tight junction protein quantification
Time Frame
before and after 6 weeks of each treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clive Wilder-Smith, MD
Phone
+41313123737
Email
info@braingut.com
Facility Information:
Facility Name
Gastroenterology Group Practice / Brain-Gut Research Group
City
Bern
ZIP/Postal Code
3011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clive Wilder-Smith, MD
Phone
+41313123737
Email
info@ggp.ch

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs