NCT01958034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

September 27, 2013

Last Update Submit

October 9, 2016

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 6 minutes walk test

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

    2 months

Secondary Outcomes (2)

  • C-reactive protein

    Baseline and 2 months

  • Inflammatory markers and markers of heart function

    Baseline and 2 months

Study Arms (2)

Dietary supplement with bilberry extract

EXPERIMENTAL

Billberry powder 3 times daily for 2 months.

Dietary Supplement: Bilberry extract

Control

NO INTERVENTION

No dietary supplement with bilberry extract

Interventions

Bilberry extractDIETARY_SUPPLEMENT
Dietary supplement with bilberry extract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Orebro University Hospital

Örebro, Örebro County, 70185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30803503DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Vaccinium myrtillus extract

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ole Frobert, MD, PhD

    Department of Cardiology, Orebro University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 8, 2013

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

SE(1)