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Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial) (BEAR SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01958034
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Dietary Supplement: Bilberry extract Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Study Start Date : February 2014
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dietary supplement with bilberry extract
Billberry powder 3 times daily for 2 months.
Dietary Supplement: Bilberry extract
No Intervention: Control
No dietary supplement with bilberry extract


Outcome Measures

Primary Outcome Measures :
  1. 6 minutes walk test [ Time Frame: 2 months ]
    The effect of intervention on a standardized physical challenge - the 6 minutes walk test


Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: Baseline and 2 months ]
    The effect of intervention on the inflammatory marker CRPö

  2. Inflammatory markers and markers of heart function [ Time Frame: Baseline and 2 months ]
    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,


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958034


Locations
Sweden
Department of Cardiology, Orebro University Hospital
Orebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Investigators
Principal Investigator: Ole Frobert, MD, PhD Department of Cardiology, Orebro University Hospital, Sweden
More Information

Responsible Party: Ole Frobert, MD, PhD, MD, PhD, Region Örebro County
ClinicalTrials.gov Identifier: NCT01958034     History of Changes
Other Study ID Numbers: 2013-06-05
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases