Effects of Bilberry and Oat Intake After AMI (BIOAMI)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    900
  • sponsor
    Ole Frobert, MD, PhD
Updated on 11 May 2022
angiography
atorvastatin
medical therapy
myocardial infarction
stemi
infarct
percutaneous coronary intervention
secondary prevention
acute myocardial infarction

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 IdentifierNCT03620266
SponsorOle Frobert, MD, PhD
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

STEMI or NSTEMI
Completed coronary angiography/PCI
Male and female subjects ≥18 years
Allocated to atorvastatin at a daily dose of 80 mg
Written informed consent

Exclusion Criteria

Emergency coronary artery bypass grafting
<18 years of age
LDL cholesterol <2.0 mmol/L
Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of >15 g of oatmeal or equivalent
Food allergy/intolerance to gluten, bilberries or legumes
Previous randomization in the BIOAMI trial
Inability to provide informed consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note