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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Bilberry extract
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Cardiology, Orebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dietary supplement with bilberry extract

Control

Arm Description

Billberry powder 3 times daily for 2 months.

No dietary supplement with bilberry extract

Outcomes

Primary Outcome Measures

6 minutes walk test
The effect of intervention on a standardized physical challenge - the 6 minutes walk test

Secondary Outcome Measures

C-reactive protein
The effect of intervention on the inflammatory marker CRPö
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,

Full Information

First Posted
September 27, 2013
Last Updated
October 9, 2016
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT01958034
Brief Title
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Acronym
BEAR SMART
Official Title
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement with bilberry extract
Arm Type
Experimental
Arm Description
Billberry powder 3 times daily for 2 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No dietary supplement with bilberry extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Bilberry extract
Primary Outcome Measure Information:
Title
6 minutes walk test
Description
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
Time Frame
2 months
Secondary Outcome Measure Information:
Title
C-reactive protein
Description
The effect of intervention on the inflammatory marker CRPö
Time Frame
Baseline and 2 months
Title
Inflammatory markers and markers of heart function
Description
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,
Time Frame
Baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Frobert, MD, PhD
Organizational Affiliation
Department of Cardiology, Orebro University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Orebro University Hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30803503
Citation
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.
Results Reference
derived

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

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