Effects of Bilberry and/or Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): a randomized, double-blind, placebo-controlled trial

The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. Our objective is to investigate the potential benefit of standard treatment after AMI supplemented with daily bilberry and/or oat dietary intake. Our primary aim is to assess the effect of a 3-month intervention with bilberries and oats, individually or combined, on cardiovascular risk markers such as lipids, inflammation and physical exercise capacity after AMI. A secondary aim is to assess to what extent gut microbiota composition may explain differences among responders and non-responders to bilberry, oats or their combination and if such differential response pattern is mirrored in the plasma metabolome.

Patients who have undergone invasive treatment for AMI will be asked to participate in the study involving randomization to a 3-month food supplement with either 1) concentrated bilberries, 2) concentrated oats; 3) bilberries and oats in combination or 4) placebo. At study start and after 3 months, blood and stool samples are collected and physical performance is evaluated. The study is initiated by and coordinated from Örebro and five other hospitals will also participate. Study start is January 2021. Long-term follow-up is performed via patient registries.

Although new lipid lowering medications are effective in lowering LDL cholesterol levels, their cost-efficiency is debatable even in high-risk patients. Bilberry and/or oat intake with a potential LDL lowering effect, in a patient population already undergoing statin treatment might be utilized as new inexpensive and safe supplementary option to better prevent future cardiovascular events in AMI patients.

Collaborators
Universitetssjukhuset i Örebro, prof Ole Fröbert
Skånes Universitetssjukhus Lund, prof David Erlinge
Sahlgrenska Universitetssjukhuset, Carlo Pirazzi MD, PhD
Centralsjukhuset i Karlstad, Payam Khalili MD
Västmanlands sjukhus Västerås Amra Kåregren, MD
Chalmers tekniska högskola prof Rikard Landberg
Glucanova AB
Immun AB