Myocardial InfarctionBioDiaMINCT03620266
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
A study testing Bilberry, Bioprocessed oat bran and Combination bilberry/oats in people with Myocardial Infarction, run by Ole Frobert, MD, PhD at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Bilberry, Bioprocessed oat bran and Combination bilberry/oats
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Sep 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Sweden6 sites
Falu lasarett
Falun
Sahlgrenska Universitetssjukhuset
Gothenburg
Karlstad general hospital
Karlstad
Department of Cardiology, Skånes universitetssjukhus
Lund, 221 00
Department of Cardiology, Örebro University Hospital
Örebro, 701 85
Cardiology Clinic, Västmanlands sjukhus
Västerås, 721 89
About this study
Official title: 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.
Read more
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.
- Conditions
- Myocardial Infarction
- Being tested
- Bilberry, Placebo, Bioprocessed oat bran, Combination bilberry/oats
- Keywords
- acute myocardial infarction, diet therapy, anthocyanin, bilberry bush, exercise capacity, cholesterol, beta glucans, type 2 diabetes mellitus
- Medical subject headings
- Myocardial Infarction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilberryDietary supplement
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.
PlaceboDietary supplement
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.
Bioprocessed oat branDietary supplement
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.
Combination bilberry/oatsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilberry | Experimental | 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. Receives: Dietary Supplement: Bilberry |
| Reference/Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Bioprocessed oat bran | Experimental | 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. Receives: Dietary Supplement: Bioprocessed oat bran |
| Combination of oat and bilberry | Experimental | 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. Receives: Dietary Supplement: Combination bilberry/oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of LDL cholesterol
The effect of intervention on difference between the groups of LDL cholesterol after three months
Measured: Three months
Secondary outcomes (33)
Plasma lipid profile
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.
Measured: Three months
Symptom-limited bicycle ergometer test
The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))
Measured: Three months
Dynamic unilateral heel-lft and unilateral shoulder flexion tests
The effect of intervention on muscle endurance
Measured: Three months
Self-reported physical activity level
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)
Measured: Three months
Plasma Cardiac Troponin Concentration
Change in plasma cardiac troponin (high-sensitivity cardiac troponin T or I) concentration from baseline to 3 months to assess myocardial injury.
The effect of intervention on Troponin levels, Unit of Measure: ng/L
Measured: Three months
Plasma NT-proBNP Concentration
Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to 3 months to assess cardiac stress, pg/mL
Measured: Three months
Plasma hs-CRP Concentration
Change in plasma high-sensitivity C-reactive protein (hs-CRP) concentration from baseline to 3 months to assess systemic inflammation.
Unit of Measure: mg/L
Measured: Three months
Plasma IL-6 Concentration
Change in plasma interleukin-6 (IL-6) concentration from baseline to 3 months to assess inflammatory response.
Unit of Measure: pg/mL
Measured: Three months
Glycosylated Hemoglobin (HbA1c)
Change in glycosylated hemoglobin (HbA1c) from baseline to 3 months to assess glycemic control.
Unit of Measure: %
Measured: Three months
Fasting Plasma Insulin Concentration
Change in fasting plasma insulin concentration from baseline to 3 months to assess insulin sensitivity and metabolic status.
Unit of Measure: µIU/mL (micro-international units per milliliter)
Measured: Three months
Fasting Plasma C-Peptide Concentration
Change in fasting plasma C-peptide concentration from baseline to 3 months to assess endogenous insulin secretion and beta-cell function.
Unit of Measure: ng/mL
Measured: Three months
Serum Creatinine Concentration
Change in serum creatinine concentration from baseline to 3 months to assess renal function.
Unit of Measure: mg/dL
Measured: Three months
Fasting Plasma Glucose Concentration
Change in fasting plasma glucose concentration from baseline to 3 months to assess glycemic control.
Unit of Measure: mg/dL
Unit of Measure: mg/dL
Measured: Three months
Serum Cystatin C Concentration
Change in serum cystatin C concentration from baseline to 3 months to assess renal function and estimate glomerular filtration independent of muscle mass.
Unit of Measure: mg/L
Unit of Measure: mg/dL
Unit of Measure: mg/dL
Measured: Three months
Untargeted plasma metabolome
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.
Measured: Three months
Fecal samples of gut microbiota composition
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.
Measured: Three months
Left ventricular systolic function
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
Measured: Three months
Resting heart rate
The effect of intervention on resting heart rate
Measured: Three months
Systolic and diastolic blood pressure
The effect of intervention on blood pressure (mmHg)
Measured: Three months
Urine albumin-creatinine ratio
Urine albumin-creatinine ratio will be measured for for T2DM only
Measured: Three months
Continuous glucose monitoring with Continuous Glucose Monitors (CGM) - FreeStyle model 2
Continuous glucose monitoring (in a subset of T2DM only, n=100 in total)
Measured: Three months
Body composition with multi-frequency bioimpedance
The effect of intervention on body composition measured with multi-frequency bioimpedance (for T2DM only)
Measured: Three months
Diabetic retinal changes
The effect of intervention on diabetic retinal changes (eye fundus examination) (in a subset of T2DM only, n=100 in total)
Measured: Three months
Platelet aggregation (Primary hemostasis)
Ex vivo platelet aggregation in whole blood measured with impedance aggregometry (Multiplate®, Roche, Switzerland) after stimulation with adenosine diphosphate (ADP), arachidonic acid and thrombin-related activation peptide (TRAP-6). Unit of measure: Aggregation units x min. (in a subset of T2DM only, n=100 in total)
Measured: Three months
P-selectin levels (Primary hemostasis)
Plasma concentration of P-selectin measured with commercial ELISA (CD62P Quantikine, Biotechne, Dublin, Ireland). Unit of measure: ng/mL. (in a subset of T2DM only, n=100 in total)
Measured: Three months
Ex vivo thrombin generation (Secondary hemostasis)
Ex vivo thrombin generation (endogenous thrombin potential) in platelet-poor plasma measured using Calibrated Automated Thrombogram (BV Thrombinoscope, Maastricht, the Netherlands) after stimulation with tissue factor. Unit of measure: nM x min. (in a subset of T2DM only, n=100 in total)
Measured: Three months
Prothrombin fragment 1+2 (Secondary hemostasis)
Plasma concentration of prothrombin fragment 1+2, measured with commercial ELISA (EnzygnostTM, Siemens Healthineers, Ballerup, Denmark). Unit of measure: pmol/L. (in a subset of T2DM only, n=100 in total)
Measured: Three months
Fibrinolysis speed
Ex vivo fibrinolytic capacity (fibrinolysis speed) in whole blood measured with in-house modified rotational thromboelastometry after stimulation with tissue factor and tissue plasminogen activator. Unit of measure: mm/min. (in a subset of T2DM only, n=100 in total)
Measured: Three months
Fibrinolytic capacity
Ex vivo fibrinolytic capacity (time from peak fibrin to 50% lysis) in platelet-poor plasma measured with in-house turbidimetric fibrin formation and lysis assay. Unit of measure: seconds. (in a subset of T2DM only, n=100 in total)
Measured: Three months
Fibrinolytic markers
Plasma concentrations of plasminogen activity, tissue plasminogen activator (unit of measure: ng/mL) and plasminogen activator inhibitor-1 (unit of measure: ng/mL) measured with ELISA (Technozym®, Technoclone, Vienna, Austria). (in a subset of T2DM only, n=100 in total)
Measured: Three months
Endothelial activation
Plasma concentrations of syndecan-1 (unit of measure: ng/mL) and thrombomodulin (unit of measure: ng/mL) measured with commercial ELISA kits (CD138 kit and CD141 kit, Diaclone, Medix Biochemica, Espoo, Finland). (in a subset of T2DM only, n=100 in total)
Measured: Three months
Inflammation
The effect of intervention on inflammatory markers (Olink panel) (in a subset of T2DM only, n=100 in total)
Measured: Three months
Oxidative stress
The effect of intervention on 8-Oxo-2'-deoxyguanosine levels (in a subset of T2DM only, n=100 in total)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start30 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole Frobert, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västmanland, Region Skane, Chalmers University of Technology, Värmland County Council, Sweden, Vastra Gotaland Region, Aarhus University Hospital, Odense University Hospital, Falu Hospital
- Responsible party
- Sponsor-investigator, Ole Frobert, MD, PhD, Region Örebro County
- Investigators
- Ole Frobert, Prof, Study director, Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, SwedenCecilia Bergh, PhD, Principal investigator, Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620266
- Sponsor's protocol ID
- BioDiaMI
- Acronym
- BioDiaMI
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2018
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergh C, Landberg R, Andersson K, Heyman-Linden L, Rascon A, Magnuson A, Khalili P, Karegren A, Nilsson J, Pirazzi C, Erlinge D, Frobert O. Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2021 May 10;22(1):338. doi: 10.1186/s13063-021-05287-5.
PubMed 33971938
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03620266
- Acronym / sponsor ID
- BioDiaMI / BioDiaMI
- Conditions
- Myocardial Infarction
- Keywords
- acute myocardial infarction, diet therapy, anthocyanin, bilberry bush, exercise capacity, cholesterol, beta glucans, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ole Frobert, MD, PhDUniversity, hospital or other
- Collaborators
- Region Västmanland, Region Skane, Chalmers University of Technology, Värmland County Council, Sweden, Vastra Gotaland Region, Aarhus University Hospital, Odense University Hospital, Falu Hospital
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bilberry | Experimental | Dietary Supplement: BilberryDietary 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. |
| Reference/Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary 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. |
| Bioprocessed oat bran | Experimental | Dietary Supplement: Bioprocessed oat branDietary 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. |
| Combination of oat and bilberry | Experimental | Dietary Supplement: Combination bilberry/oatsDietary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BilberryThe 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. | Dietary supplement | Bilberry |
| PlaceboThe 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. | Dietary supplement | Reference/Placebo |
| Bioprocessed oat branThe 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. | Dietary supplement | Bioprocessed oat bran |
| Combination bilberry/oatsThe 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. | Dietary supplement | Combination of oat and bilberry |
Primary outcome
Plasma levels of LDL cholesterol
Time frame: Three months
The effect of intervention on difference between the groups of LDL cholesterol after three months
33 secondary outcomes
Plasma lipid profile
Time frame: Three months
Symptom-limited bicycle ergometer test
Time frame: Three months
Dynamic unilateral heel-lft and unilateral shoulder flexion tests
Time frame: Three months
Self-reported physical activity level
Time frame: Three months
Plasma Cardiac Troponin Concentration
Time frame: Three months
Plasma NT-proBNP Concentration
Time frame: Three months
Plasma hs-CRP Concentration
Time frame: Three months
Plasma IL-6 Concentration
Time frame: Three months
Glycosylated Hemoglobin (HbA1c)
Time frame: Three months
Fasting Plasma Insulin Concentration
Time frame: Three months
Fasting Plasma C-Peptide Concentration
Time frame: Three months
Serum Creatinine Concentration
Time frame: Three months
Fasting Plasma Glucose Concentration
Time frame: Three months
Serum Cystatin C Concentration
Time frame: Three months
Untargeted plasma metabolome
Time frame: Three months
Fecal samples of gut microbiota composition
Time frame: Three months
Left ventricular systolic function
Time frame: Three months
Resting heart rate
Time frame: Three months
Systolic and diastolic blood pressure
Time frame: Three months
Urine albumin-creatinine ratio
Time frame: Three months
Continuous glucose monitoring with Continuous Glucose Monitors (CGM) - FreeStyle model 2
Time frame: Three months
Body composition with multi-frequency bioimpedance
Time frame: Three months
Diabetic retinal changes
Time frame: Three months
Platelet aggregation (Primary hemostasis)
Time frame: Three months
P-selectin levels (Primary hemostasis)
Time frame: Three months
Ex vivo thrombin generation (Secondary hemostasis)
Time frame: Three months
Prothrombin fragment 1+2 (Secondary hemostasis)
Time frame: Three months
Fibrinolysis speed
Time frame: Three months
Fibrinolytic capacity
Time frame: Three months
Fibrinolytic markers
Time frame: Three months
Endothelial activation
Time frame: Three months
Inflammation
Time frame: Three months
Oxidative stress
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 33971938Bergh C, Landberg R, Andersson K, Heyman-Linden L, Rascon A, Magnuson A, Khalili P, Karegren A, Nilsson J, Pirazzi C, Erlinge D, Frobert O. Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2021 May 10;22(1):338. doi: 10.1186/s13063-021-05287-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Frobert, Prof study director
Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden
Cecilia Bergh, PhD principal investigator
Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilberry, Bioprocessed oat bran and Combination bilberry/oats in people with Myocardial Infarction, run by Ole Frobert, MD, PhD at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of LDL cholesterol (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.