Myocardial InfarctionPhase 4BEAR SMARTNCT01958034
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
A Phase 4 study testing Bilberry extract in people with Myocardial Infarction, run by Region Örebro County at 1 site in Sweden.
Trial summary
In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Bilberry extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- Patients with a diagnosis of non-STEMI as defined by a combination of; onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an MI.
Who cannot join
- Need for emergency coronary artery bypass grafting
- Inability to provide informed consent
- Age below 18 years
- Previous randomization in the BEAR SMART trial
- A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
- Need for emergency coronary artery bypass grafting
Show all 10Show fewer
- Inability to provide informed consent
- Age below 18 years
- Previous randomization in the BEAR SMART trial
- A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, Orebro University Hospital
Örebro, Örebro County, 70185
About this study
In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in cardiovascular disease: lipids, inflammation, oxidative stress and heart function.
Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to "bilberry placebo powder" we have amended to the protocoll that the trial design is changed from blinded to open and that the bilberry arm of the trial carries on in an open design and that the control group will receive no dietary supplement.
- Conditions
- Myocardial Infarction
- Being tested
- Bilberry extract
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilberry extractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement with bilberry extract | Experimental | Billberry powder 3 times daily for 2 months. Receives: Dietary Supplement: Bilberry extract |
| Control | No intervention | No dietary supplement with bilberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
Measured: 2 months
Secondary outcomes (2)
C-reactive protein
The effect of intervention on the inflammatory marker CRPö
Measured: Baseline and 2 months
Inflammatory markers and markers of heart function
The effect of intervention on markers of inflammation: IL-6 (interleukin 6), TNF-α (tumor necrosis factor α), INF-γ (interferon γ), markers of oxidative stress: oxidized LDL, carbonylated proteins, 2-OHDG, H2O2, hexanoyl L lysine, nitrogen oxide synthase (NOS), markers of myocardial damage and heart failure: BNP (brain natriuretic peptide) and troponin I, markers of endothelial function: VEGF (vascular endothelial growth factor), 8-isoprostane, E-selectin, measures of plasma lipids; total cholesterol, LDL-cholesterol, TGA (triacylglycerides), and measures of patient compliance and biological effect of bilberry supplementation: quercetin,
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Frobert, MD, PhD, Region Örebro County
- Investigators
- Ole Frobert, MD, PhD, Principal investigator, Department of Cardiology, Orebro University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958034
- Sponsor's protocol ID
- 2013-06-05
- Acronym
- BEAR SMART
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Arevstrom L, Bergh C, Landberg R, Wu H, Rodriguez-Mateos A, Waldenborg M, Magnuson A, Blanc S, Frobert O. Freeze-dried bilberry (Vaccinium myrtillus) dietary supplement improves walking distance and lipids after myocardial infarction: an open-label randomized clinical trial. Nutr Res. 2019 Feb;62:13-22. doi: 10.1016/j.nutres.2018.11.008. Epub 2018 Nov 17.
PubMed 30803503
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
- ClinicalTrials.gov ID
- NCT01958034
- Acronym / sponsor ID
- BEAR SMART / 2013-06-05
- Conditions
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in cardiovascular disease: lipids, inflammation, oxidative stress and heart function.
Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to "bilberry placebo powder" we have amended to the protocoll that the trial design is changed from blinded to open and that the bilberry arm of the trial carries on in an open design and that the control group will receive no dietary supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement with bilberry extract | Experimental | Dietary Supplement: Bilberry extractBillberry powder 3 times daily for 2 months. |
| Control | No intervention | –No dietary supplement with bilberry extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- Patients with a diagnosis of non-STEMI as defined by a combination of; onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an MI.
Key exclusion criteria (10 listed)
- Need for emergency coronary artery bypass grafting
- Inability to provide informed consent
- Age below 18 years
- Previous randomization in the BEAR SMART trial
- A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilberry extract | Dietary supplement | Dietary supplement with bilberry extract |
Primary outcome
6 minutes walk test
Time frame: 2 months
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
2 secondary outcomes
C-reactive protein
Time frame: Baseline and 2 months
Inflammatory markers and markers of heart function
Time frame: Baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 30803503Arevstrom L, Bergh C, Landberg R, Wu H, Rodriguez-Mateos A, Waldenborg M, Magnuson A, Blanc S, Frobert O. Freeze-dried bilberry (Vaccinium myrtillus) dietary supplement improves walking distance and lipids after myocardial infarction: an open-label randomized clinical trial. Nutr Res. 2019 Feb;62:13-22. doi: 10.1016/j.nutres.2018.11.008. Epub 2018 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Frobert, MD, PhD principal investigator
Department of Cardiology, Orebro University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bilberry extract in people with Myocardial Infarction, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walk test (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.