Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)|
- 6 minutes walk test [ Time Frame: 2 months ] [ Designated as safety issue: No ]The effect of intervention on a standardized physical challenge - the 6 minutes walk test
- C-reactive protein [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]The effect of intervention on the inflammatory marker CRPö
- Inflammatory markers and markers of heart function [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]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,
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Dietary supplement with bilberry extract
Billberry powder 3 times daily for 2 months.
|Dietary Supplement: Bilberry extract|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958034
|Contact: Ole Frobert, MD, PhD||46 19 602 54 firstname.lastname@example.org|
|Department of Cardiology, Orebro University Hospital||Recruiting|
|Orebro, Sweden, 70185|
|Contact: Ole Frobert, MD, PhD 46 19 602 54 13 email@example.com|
|Principal Investigator: Ole Frobert, MD, PhD|
|Principal Investigator:||Ole Frobert, MD, PhD||Department of Cardiology, Orebro University Hospital, Sweden|