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
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 55 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Brain-Gut Research Group is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Freeze-dried pure blueberry powder
Dietary Supplement: Blueberry
Maltodextrin powder.
Dietary Supplement: Placebo
freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
matched powder maltodextrin twice daily = 60kcal
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Validated scale of GI symptoms
Time frame: before and after 6 weeks of each treatment arm
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
Started Jan 2020 (actual). Primary completion is estimated for Dec 2021, 23 months after the start.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 23 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Blueberry extract
Brain-Gut Research Group