Effects of Bilberry and Oat Intake After AMI (BIOAMI)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2023
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- participants needed
- 900
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- sponsor
- Ole Frobert, MD, PhD
Summary
- 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.
- Design
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.
- Implications
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.
Details
| Condition | Myocardial Infarction |
|---|---|
| Treatment | Placebo, Bilberry, Bioprocessed oat bran, Combination bilberry/oats |
| Clinical Study Identifier | NCT03620266 |
| Sponsor | Ole Frobert, MD, PhD |
| Last Modified on | 11 May 2022 |
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