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Berry and oat shakes tested as Heart-Health boosters

NCT ID NCT03620266

Disease control Sponsor: Ole Frobert, MD, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether daily shakes made from bilberries and oats can lower LDL cholesterol and improve exercise capacity in people who have had a heart attack or have type 2 diabetes. 900 participants will drink either a bilberry shake, an oat shake, a combination shake, or a placebo shake twice a day for three months. The goal is to see if these simple dietary additions can provide extra heart protection on top of standard medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bilberry and oat shakes
What this could lead to
If it works, this could offer a simple, safe dietary strategy to help manage cholesterol and inflammation in people with heart disease or diabetes.
What could go wrong
This is a mid-sized study, not a large final-stage trial. The effects may be small or not clinically meaningful, and the shakes are taken alongside standard medications, not replacing them.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Confirmed T2DM diagnosis (any treatment modality accepted) and/or within 3 years post STEMI or NSTEMI * Completed coronary angiography/PCI * Male and female subjects ≥18 years * Allocated to atorvastatin at a daily dose of 80 mg (only eligible for patients enrolled up to 7 days post MI and not for T2D subjects) * 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 BioDiaMI trial * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

myocardial infarction type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocardial infarction

Contacts and locations

Locations

  • Cardiology Clinic, Västmanlands sjukhus

    Västerås, 721 89, Sweden

  • Department of Cardiology, Skånes universitetssjukhus

    Lund, 221 00, Sweden

  • Department of Cardiology, Örebro University Hospital

    Örebro, 701 85, Sweden

  • Falu lasarett

    Falun, Sweden

  • Karlstad general hospital

    Karlstad, Sweden

  • Odense University Hospital

    Odense, Denmark

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Sweden

  • Steno Diabetes center

    Aarhus, Denmark

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