Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
Launched by OLE FROBERT, MD, PHD · Aug 2, 2018
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of bilberry and oat intake on heart health for patients who have type 2 diabetes or have recently experienced a heart attack (myocardial infarction). Researchers want to find out if adding dried bilberry and special oat bran to the diet can lower bad cholesterol (LDL) and improve exercise capacity compared to a standard supplement. Participants will be randomly assigned to one of four groups for three months, and the study will also look at other health markers like inflammation and blood sugar levels.
To be eligible for the trial, participants should be at least 18 years old and have a confirmed diagnosis of type 2 diabetes or have had a heart attack within the last three years. They should also be on a specific cholesterol-lowering medication called atorvastatin. Participants will receive guidance on what to expect during the trial, including regular check-ins and assessments of their health. This study aims to explore a safe and cost-effective dietary approach to help reduce health risks for individuals with diabetes and heart issues.
Gender
ALL
Eligibility criteria
- • 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
About Ole Frobert, Md, Phd
Dr. Ole Frobert, MD, PhD, is a distinguished clinical trial sponsor with extensive expertise in cardiovascular medicine and clinical research. With a robust academic background and a commitment to advancing healthcare, Dr. Frobert leads innovative studies aimed at improving patient outcomes through evidence-based therapies. His collaborative approach fosters strong partnerships within the research community, ensuring rigorous methodologies and adherence to ethical standards. Dr. Frobert's dedication to scientific excellence and patient-centered care positions him as a pivotal figure in the development of novel treatment strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Odense, , Denmark
Falun, , Sweden
Gothenburg, , Sweden
Karlstad, , Sweden
Lund, , Sweden
Västerås, , Sweden
örebro, , Sweden
Aarhus, , Denmark
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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