Effects of Bilberry and Oat Intake After AMI (BIOAMI)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Ole Frobert, MD, PhD
Updated on 11 May 2022
medical therapy
myocardial infarction
percutaneous coronary intervention
secondary prevention
acute myocardial infarction



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 following acute myocardial infarction (AMI), but 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.


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, initiated within five days following percutaneous coronary intervention for AMI. 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, metabolomics and gut microbiota composition after three months.


Secondary prevention after AMI has improved during the last decades but readmissions and death following AMI remain large health care challenges. Controlling hyperlipidemia 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 after AMI.

Condition Myocardial Infarction
Treatment Placebo, Bilberry, Bioprocessed oat bran, Combination bilberry/oats
Clinical Study IdentifierNCT03620266
SponsorOle Frobert, MD, PhD
Last Modified on11 May 2022


Yes No Not Sure

Inclusion Criteria

Completed coronary angiography/PCI
Male and female subjects ≥18 years
Allocated to atorvastatin at a daily dose of 80 mg
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 BIOAMI trial
Inability to provide informed consent
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