Effects of bilberry and oat intake on heart health after diabetes or heart attack
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
This study is testing whether adding dried bilberry and oat bran to the diet can help improve heart health in people with type 2 diabetes or those who have had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Locations | 8 sites (Aarhus and 7 other locations) |
| Trial ID | NCT03620266 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the cardioprotective effects of dietary supplementation with dried bilberry and bioprocessed oat bran in patients with type 2 diabetes and/or those who have experienced a myocardial infarction. It is a double-blind, randomized, placebo-controlled trial designed to assess the individual and combined effects of these dietary interventions on cardiometabolic risk factors. The study aims to provide robust evidence on the potential benefits of these natural products in improving heart health and exercise capacity in affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of type 2 diabetes and/or within three years post-myocardial infarction.
Not a fit: Patients who have undergone emergency coronary artery bypass grafting or have significant food allergies to bilberries or oats may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that significantly improve heart health and metabolic outcomes for patients with type 2 diabetes and a history of myocardial infarction.
How similar studies have performed: While smaller studies have suggested potential benefits of bilberry and oats, this study is novel in its approach to evaluate their combined effects on cardiometabolic health in a larger population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus and 7 other locations
- Steno Diabetes center — Aarhus, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Falu lasarett — Falun, Sweden (Not_yet_recruiting)
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
- Karlstad general hospital — Karlstad, Sweden (Recruiting)
- Department of Cardiology, Skånes universitetssjukhus — Lund, Sweden (Recruiting)
- Cardiology Clinic, Västmanlands sjukhus — Västerås, Sweden (Recruiting)
- Department of Cardiology, Örebro University Hospital — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Cecilia Bergh, PhD — Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
- Study coordinator: Ole Frobert, Prof
- Email: ole.frobert@regionorebrolan.se
- Phone: +46 19 602 543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.