Abstract
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.
Highlights
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
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
The primary objective is to assess differences in low-density lipoprotein (LDL) cholesterol change among treatments after 3 months of a diet supplemented with a beverage containing either dried bilberry or bioprocessed oat bran compared with a neutral isocaloric reference drink, initiated within 5 days following percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)
Summary
Hypotheses, and primary and secondary endpoints The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a prospective, randomized, double-blind, placebo-controlled multicenter trial in patients post-AMI. The primary objective is to assess differences in LDL cholesterol change among treatments after 3 months of a diet supplemented with a beverage containing either dried bilberry or bioprocessed oat bran compared with a neutral isocaloric reference drink, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI. Data management, and statistical analysis To the best of our knowledge, no previous intervention study of bilberry/oats with LDL cholesterol as an endpoint in AMI patients has been conducted. Required sample size is calculated on the basis of bilberry-specific interventions from four smaller randomized studies in at-risk populations [18], from our pilot study [27], and from the IMPROVE-IT trial [44], which found a clinically relevant LDL cholesterol-lowering effect of − 0.4 mmol/L when adding treatment with a non-statin agent to standard statin lipid-lowering therapy after AMI. Any side effects of the bilberry, oat or reference/placebo products will be registered according to 7b World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System embedded in the eCRF
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