- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620266
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI (BioDiaMI)
Effects of Bilberry and Oat Intake on Plasma Lipid Profile, Inflammation, and Exercise Capacity in Patients With Type 2 Diabetes and/or Myocardial Infarction (BioDiaMI): a Randomized, Double-blind, Placebo-controlled Trial
Background:
Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits for patients with manifest chronic cardiometabolic disease, such as type 2 diabets mellitus (T2DM) and myocardial infarction (MI). However, large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors.
Design:
This is a double-blind, randomized, placebo-controlled clinical trial. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry and with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, for patients diagnosed with T2DM and/or MI. Patients will be randomized 1:1:1:1 to a three-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after three months. The major secondary endpoint is exercise capacity at three months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, glycaemia, and gut microbiota composition after three months.
Implications:
Secondary prevention after cardiometabolic disease, including T2DM and MI, has improved during the last decades but diabetes complications, readmissions and cadiovascular related deaths following these conditions remain large health care challenges. Controlling hyperlipidemia, hyperglycaemia, hypertension and inflammation is critical to preventing (new) cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention in high-risk patients or risk prevention in subjects with T2DM.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ole Frobert, Prof
- Phone Number: +46 19 602 543
- Email: ole.frobert@regionorebrolan.se
Study Contact Backup
- Name: Cecilia Bergh, PhD
- Phone Number: +46 730 68 28 92
- Email: cecilia.bergh@regionorebrolan.se
Study Locations
-
-
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Aarhus, Denmark
- Not yet recruiting
- Steno Diabetes center
-
Contact:
- Sören Gregersen, Prof
-
Odense, Denmark
- Recruiting
- Odense University Hospital
-
Contact:
- Mona El Faramawi, MD
-
-
-
-
-
Falun, Sweden
- Not yet recruiting
- Falu Lasarett
-
Contact:
- Kristina Hambreaus, MD
-
Gothenburg, Sweden
- Recruiting
- Sahlgrenska Universitetssjukhuset
-
Contact:
- Carlo Pirazzi, MD, PhD
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Karlstad, Sweden
- Recruiting
- Karlstad general hospital
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Contact:
- Payam Khalili, MD, PhD
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Lund, Sweden, 221 00
- Recruiting
- Department of Cardiology, Skånes universitetssjukhus
-
Contact:
- David Ehrlinge, prof
- Phone Number: tel:+46 46 17 25 97
- Email: david.erlinge@med.lu.se
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Västerås, Sweden, 721 89
- Recruiting
- Cardiology Clinic, Västmanlands sjukhus
-
Contact:
- Amra Kåregren, MD
- Phone Number: +46 21 17 52 04
- Email: amra.karegren@ltv.se
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Örebro, Sweden, 701 85
- Recruiting
- Department of Cardiology, Örebro University Hospital
-
Contact:
- Cecilia Bergh, PhD
- Phone Number: +46 730 68 28 92
- Email: cecilia.bergh@regionorebrolan.se
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Contact:
- Ole Frobert, prof
- Phone Number: +46 19 602 54 13
- Email: ole.frobert@regionorebrolan.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria
- Confirmed T2DM diagnosis (any treatment modality accepted) and/or within 3 years post STEMI or NSTEMI
- Completed coronary angiography/PCI
- Male and female subjects ≥18 years
- Allocated to atorvastatin at a daily dose of 80 mg (only eligible for patients enrolled up to 7 days post MI and not for T2D subjects)
- Written informed consent
Exclusion criteria
- Emergency coronary artery bypass grafting
- <18 years of age
- LDL cholesterol <2.0 mmol/L
- Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of >15 g of oatmeal or equivalent
- Food allergy/intolerance to gluten, bilberries or legumes
- Previous randomization in the BioDiaMI trial
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilberry
Dietary supplement with bilberry shakes 2 times daily for 3 months (containing in total 40g of dried bilberry powder equalling 480 g of fresh berries per day).
Product development in collaboration with Glucanova AB.
|
The dietary intervention will continued for three months.
After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture as both oat and bilberry), for intake two times a day (t.i.d).
The formula for the shakes to be used in the intervention will be finalized during the initial project period.
|
Placebo Comparator: Reference/Placebo
Dietary supplement with reference shakes 2 times daily for 3 months (containing no active bilberry or no active oats, but with similar texture and taste as both bilberry and oat).
Product development in collaboration with Glucanova AB.
|
The dietary intervention will be continued for three months.
After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d).
The formula for the shakes to be used in the intervention will be finalized during the initial project period.
|
Experimental: Bioprocessed oat bran
Dietary supplement with bioprocessed oat bran shakes 2 times daily for 3 months (containing beta glucans from the Glucanova® technology, invented by Glucanova AB).Product development in collaboration with Glucanova AB.
|
The dietary intervention will be continued for three months.
After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d).
The formula for the shakes to be used in the intervention will be finalized during the initial project period.
|
Experimental: Combination of oat and bilberry
Dietary supplement with a combination of bioprocessed oat bran and dried bilberry (shakes) 2 times daily for 3 months.
Product development in collaboration with Glucanova AB.
|
The dietary intervention will be continued for three months.
After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d).
The formula for the shakes to be used in the intervention will be finalized during the initial project period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma levels of LDL cholesterol
Time Frame: Three months
|
The effect of intervention on difference between the groups of LDL cholesterol after three months
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma lipid profile
Time Frame: Three months
|
The effect of intervention on differences between the groups of fasting lipid profile including HDL, triglycerides, total cholesterol, small-dense LDL cholesterol, apo A, apo B, Lp(a) and oxidized LDL.
|
Three months
|
Symptom-limited bicycle ergometer test
Time Frame: Three months
|
The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))
|
Three months
|
Dynamic unilateral heel-lft and unilateral shoulder flexion tests
Time Frame: Three months
|
The effect of intervention on muscle endurance
|
Three months
|
Self-reported physical activity level
Time Frame: Three months
|
The effect of intervention on the Frändin/Grimby activity scale (6 levels of physical activity, min:1 (low activity) max:6 (heavy activity)) and the Haskell physical activity scale ("For how many days were you physically active during the last week for at least 20 minutes?", min:0 max:7)
|
Three months
|
Plasma concentrations of inflammatory and heart function markers
Time Frame: Three months
|
The effect of intervention on plasma concentrations of biochemical markers of troponin, NT-proBNP, hs_CRP (high sensitivity C-reactive protein), IL-6 and HbA1c (glycosylated hemoglobin).
|
Three months
|
Plasma concentrations of other biochemical markers
Time Frame: Three months
|
The effect if intervention on plasma concentrations of biochemical markers of insulin, creatinine, Cystatin C, glucose and C-peptide
|
Three months
|
Untargeted plasma metabolome
Time Frame: Three months
|
Untargeted plasma metabolomics will be employed to exploratively assess alterations in endogenous and exposome-related metabolites and to identify metabolites that may differ with treatment.
|
Three months
|
Fecal samples of gut microbiota composition
Time Frame: Three months
|
These exploratory analyses of will allow to investigate the extent to which gut microbiota composition and activity differs between responders and non-responders to the interventions.
|
Three months
|
Left ventricular systolic function
Time Frame: Three months
|
The effect of intervention on left ventricular function.
Baseline left ventricular systolic function, expressed as global ejection fraction in percent according to the biplane Simpson method, will be evaluated by echocardiography by the discharging physician.
The procedure will be repeated after three months by an experienced echocardiography technician blinded to results of the initial examinations
|
Three months
|
Resting heart rate
Time Frame: Three months
|
The effect of intervention on resting heart rate
|
Three months
|
Systolic and diastolic blood pressure
Time Frame: Three months
|
The effect of intervention on blood pressure (mmHg)
|
Three months
|
Urine albumin-creatinine ratio
Time Frame: Three months
|
Urine albumin-creatinine ratio will be measured for for T2DM only
|
Three months
|
Continuous glucose monitoring
Time Frame: Three months
|
Continuous glucose monitoring (in a subset of T2DM only, n=80 in total)
|
Three months
|
Body composition with multi-frequency biothesiometry
Time Frame: Three months
|
Body composition willbe measured with multi-frequency biothesiometry (for T2DM only)
|
Three months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ole Frobert, Prof, Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden
- Principal Investigator: Cecilia Bergh, PhD, Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BioDiaMI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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