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

Trials

Anders Magnuson¹  Cecilia Bergh¹  Rikard Landberg²  Payam Khalili³  David Erlinge⁴  Ole Fröbert⁵  Carlo Pirazzi⁶  Kristina Andersson⁷  Amra Kåregren⁸  Johan Nilsson⁹  Ana Rascón^1,10  Lovisa Heyman-Lindén^1,11 

[1] Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, 701 85, Örebro, Sweden;Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden;Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden;Department of Cardiology and Acute Internal Medicine, Central Hospital, Karlstad, Sweden;Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden;Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden;Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden;Department of Experimental Medical Science, Lund University, Lund, Sweden;Glucanova AB, Lund, Sweden;Department of Medicine, Hospital Region Västmanland, Västerås, Sweden;Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden;Glucanova AB, Lund, Sweden;Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden;Molecular Nutrition, Department of Experimental Medical Science, Lund University, Lund, Sweden;Berry Lab AB, Lund, Sweden;

关键词: Anthocyanin;    Anthocyanin-derived phenolic acid metabolites;    Bilberry;    Cholesterol;    Diet therapy;    Exercise test;    Inflammation;    Myocardial infarction;   

DOI  :  10.1186/s13063-021-05287-5

来源: Springer

【 摘 要 】

BackgroundBilberries 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.MethodsThe 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.DiscussionControlling 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 registrationClinicalTrials.gov NCT03620266. Registered on August 8, 2018.

【 授权许可】

CC BY