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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement with bilberry extract | Experimental | Billberry powder 3 times daily for 2 months. |
|
| Control | No Intervention | No dietary supplement with bilberry extract |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilberry extract | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 minutes walk test | The effect of intervention on a standardized physical challenge - the 6 minutes walk test | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | The effect of intervention on the inflammatory marker CRPö | 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, |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole Frobert, MD, PhD | Department of Cardiology, Orebro University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Orebro University Hospital | Örebro | Örebro County | 70185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30803503 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C073305 | Vaccinium myrtillus extract |
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| Baseline and 2 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |