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
Journal article, 2021

Background: 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. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI. Methods: 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. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months. Discussion: 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. Trial registration: ClinicalTrials.gov NCT03620266. Registered on August 8, 2018.

Anthocyanin-derived phenolic acid metabolites

Exercise test

Myocardial infarction

Anthocyanin

Bilberry

Inflammation

Cholesterol

Diet therapy

Author

Cecilia Bergh

Örebro University

Rikard Landberg

Chalmers, Biology and Biological Engineering, Food and Nutrition Science

Umeå University

Kristina Andersson

Glucanova AB

Institutionen för Experimentell Medicinsk Vetenskap

Lovisa Heyman-Lindén

Berry Lab AB

Institutionen för Experimentell Medicinsk Vetenskap

Ana Rascón

Lund University

Glucanova AB

Anders Magnuson

Örebro University

Payam Khalili

Karlstad Central Hospital

Amra Kåregren

Västmanland Hospital

Johan Nilsson

Umeå University

Carlo Pirazzi

Sahlgrenska University Hospital

David Erlinge

Lund University

Ole Fröbert

Örebro University

Trials

1745-6215 (ISSN)

Vol. 22 1 338

Subject Categories

Physiotherapy

Cardiac and Cardiovascular Systems

Nutrition and Dietetics

DOI

10.1186/s13063-021-05287-5

PubMed

33971938

More information

Latest update

6/1/2021 2