Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-02 @ 12:57 AM
Study NCT ID:
NCT03620266
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073305', 'term': 'Vaccinium myrtillus extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma levels of LDL cholesterol', 'timeFrame': 'Three months', 'description': 'The effect of intervention on difference between the groups of LDL cholesterol after three months'}], 'secondaryOutcomes': [{'measure': 'Plasma lipid profile', 'timeFrame': 'Three months', 'description': '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.'}, {'measure': 'Symptom-limited bicycle ergometer test', 'timeFrame': 'Three months', 'description': 'The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))'}, {'measure': 'Dynamic unilateral heel-lft and unilateral shoulder flexion tests', 'timeFrame': 'Three months', 'description': 'The effect of intervention on muscle endurance'}, {'measure': 'Self-reported physical activity level', 'timeFrame': 'Three months', 'description': '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)'}, {'measure': 'Plasma concentrations of inflammatory and heart function markers', 'timeFrame': 'Three months', 'description': '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).'}, {'measure': 'Plasma concentrations of other biochemical markers', 'timeFrame': 'Three months', 'description': 'The effect if intervention on plasma concentrations of biochemical markers of insulin, creatinine, Cystatin C, glucose and C-peptide'}, {'measure': 'Untargeted plasma metabolome', 'timeFrame': 'Three months', 'description': '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.'}, {'measure': 'Fecal samples of gut microbiota composition', 'timeFrame': 'Three months', 'description': '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.'}, {'measure': 'Left ventricular systolic function', 'timeFrame': 'Three months', 'description': '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'}, {'measure': 'Resting heart rate', 'timeFrame': 'Three months', 'description': 'The effect of intervention on resting heart rate'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'Three months', 'description': 'The effect of intervention on blood pressure (mmHg)'}, {'measure': 'Urine albumin-creatinine ratio', 'timeFrame': 'Three months', 'description': 'Urine albumin-creatinine ratio will be measured for for T2DM only'}, {'measure': 'Continuous glucose monitoring with Continuous Glucose Monitors (CGM) - FreeStyle model 2', 'timeFrame': 'Three months', 'description': 'Continuous glucose monitoring (in a subset of T2DM only, n=80 in total)'}, {'measure': 'Body composition with multi-frequency biothesiometry', 'timeFrame': 'Three months', 'description': 'Body composition willbe measured with multi-frequency biothesiometry (for T2DM only)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute myocardial infarction', 'diet therapy', 'anthocyanin', 'bilberry bush', 'exercise capacity', 'cholesterol', 'beta glucans', 'type 2 diabetes mellitus'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '33971938', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nBilberries 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.\n\nDesign:\n\nThis 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.\n\nImplications:\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Confirmed T2DM diagnosis (any treatment modality accepted) and/or within 3 years post STEMI or NSTEMI\n* Completed coronary angiography/PCI\n* Male and female subjects ≥18 years\n* 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)\n* Written informed consent\n\nExclusion criteria\n\n* Emergency coronary artery bypass grafting\n* \\<18 years of age\n* LDL cholesterol \\<2.0 mmol/L\n* Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of \\>15 g of oatmeal or equivalent\n* Food allergy/intolerance to gluten, bilberries or legumes\n* Previous randomization in the BioDiaMI trial\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03620266', 'acronym': 'BioDiaMI', 'briefTitle': 'Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BioDiaMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilberry', 'description': '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.', 'interventionNames': ['Dietary Supplement: Bilberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference/Placebo', 'description': '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.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Bioprocessed oat bran', 'description': '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.', 'interventionNames': ['Dietary Supplement: Bioprocessed oat bran']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of oat and bilberry', 'description': '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.', 'interventionNames': ['Dietary Supplement: Combination bilberry/oats']}], 'interventions': [{'name': 'Bilberry', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Bilberry']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Reference/Placebo']}, {'name': 'Bioprocessed oat bran', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Bioprocessed oat bran']}, {'name': 'Combination bilberry/oats', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Combination of oat and bilberry']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sören Gregersen, Prof', 'role': 'CONTACT'}], 'facility': 'Steno Diabetes center', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mona El Faramawi, MD', 'role': 'CONTACT'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Falun', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Kristina Hambreaus, MD', 'role': 'CONTACT'}], 'facility': 'Falu lasarett', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Carlo Pirazzi, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Karlstad', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Payam Khalili, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Karlstad general hospital', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'zip': '221 00', 'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'David Ehrlinge, prof', 'role': 'CONTACT', 'email': 'david.erlinge@med.lu.se', 'phone': 'tel:+46 46 17 25 97'}], 'facility': 'Department of Cardiology, Skånes universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '701 85', 'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ole Frobert, prof', 'role': 'CONTACT', 'email': 'ole.frobert@regionorebrolan.se', 'phone': '+46 19 602 54 13'}, {'name': 'Cecilia Bergh, PhD', 'role': 'CONTACT', 'email': 'cecilia.bergh@regionorebrolan.se', 'phone': '+46 730 68 28 92'}], 'facility': 'Department of Cardiology, Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '721 89', 'city': 'Västerås', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Amra Kåregren, MD', 'role': 'CONTACT', 'email': 'amra.karegren@ltv.se', 'phone': '+46 21 17 52 04'}], 'facility': 'Cardiology Clinic, Västmanlands sjukhus', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'centralContacts': [{'name': 'Ole Frobert, Prof', 'role': 'CONTACT', 'email': 'ole.frobert@regionorebrolan.se', 'phone': '+46 19 602 543'}, {'name': 'Cecilia Bergh, PhD', 'role': 'CONTACT', 'email': 'cecilia.bergh@regionorebrolan.se', 'phone': '+46 730 68 28 92'}], 'overallOfficials': [{'name': 'Ole Frobert, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden'}, {'name': 'Cecilia Bergh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ole Frobert, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Västmanland', 'class': 'OTHER'}, {'name': 'Region Skane', 'class': 'OTHER'}, {'name': 'Chalmers University of Technology', 'class': 'OTHER'}, {'name': 'Värmland County Council, Sweden', 'class': 'OTHER_GOV'}, {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Falu Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ole Frobert, MD, PhD', 'investigatorAffiliation': 'Region Örebro County'}}}}