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Effects of Bilberry Dietary Supplement After Myocardial Infarction (BERRY)

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ClinicalTrials.gov Identifier: NCT03620266
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : March 27, 2019
Sponsor:
Collaborators:
Region Västmanland
Region Skane
Chalmers University of Technology
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County

Brief Summary:

Berry consumption might be utilized as a new, effective and safe supplement for prevention and control of cardiovascular disease. Accumulating evidence show that ingestion of some types of berries is associated with a wide range of beneficial biological effects on cardiovascular parameters. However, clinical trials in patients with overt disease including acute myocardial infarction (AMI) are scarce, and bilberry rich in anthocyanins might be particularly useful following an AMI.

This is a multicenter, prospective, randomized, placebo-controlled clinical trial assessing the efficacy of bilberry supplement initiated within 72 hours of percutaneous coronary intervention for AMI. Subjects Patients will be randomized 1:1 in a three-month intervention period to either bilberry powder/shake (40 g per day, equivalent to 480 g fresh berries) in combination with standard therapy or to a control group receiving placebo and standard therapy. The primary endpoint is low density lipoprotein (LDL) cholesterol change. The major secondary endpoint is exercise capacity assessed by a symptom-limited bicycle ergometer test. Other secondary endpoints include effects on inflammatory markers.

Secondary prevention after AMI has improved during the last decades but readmissions and death following AMI remain large health care challenges. Hyperlipidemia and inflammation are believed to be critical for new cardiovascular events and novel pharmacological treatments for these conditions are prohibitively expensive and associated with serious side effects. Should a bilberry supplement be able to further lower LDL cholesterol and inflammation than is standard therapy, it would have wide clinical consequences.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Dietary Supplement: Bilberry Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Dried Bilberry (Vaccinium Myrtillus) Dietary Supplement After Myocardial Infarction: a Multicenter, Prospective, Randomized, Placebo-controlled Clinical Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Bilberry
Dietary supplement with dried bilberry 3 times daily for 3 months
Dietary Supplement: Bilberry
The subjects will be instructed to use a dedicated 25 ml spoon, corresponding to 13 g, to measure a dose of dehydrated bilberry to take with meals three times a day, for a total of 40g of powder per day, equaling approximately 480g fresh berries.

Placebo Comparator: Placebo
Dietary supplement with no active bilberry 3 times daily for 3 months
Dietary Supplement: Placebo
Placebo powder containing no active bilberry




Primary Outcome Measures :
  1. LDL cholesterol [ Time Frame: Three months ]
    The effect of intervention on levels of LDL cholesterol at three months


Secondary Outcome Measures :
  1. Symptom-limited bicycle ergometer test [ Time Frame: Three months ]
    The effect of intervention on exercise capacity

  2. Dynamic unilateral heel-lft and unilateral shoulder flexion tests [ Time Frame: Three months ]
    The effect of intervention on muscle endurance

  3. Self-reported physical activity level [ Time Frame: Three months ]
    The effect of intervention on the Frändin/Grimby activity scale (6 levels of physical activity, min:1 (low activity) max:6 (heavy activity)) and the Haskell physical activity scale ("For how many days were you physically active during the last week for at least 20 minutes?", min:0 max:7)

  4. Fasting lipid levels [ Time Frame: Three months ]
    The effect of intervention on TG (total cholesterol), HDL cholesterol and TGA (triglycerides).

  5. Inflammatory markers [ Time Frame: Three months ]
    The effect of intervention on HbA1c (glycosylated hemoglobin), hs_CRP (high sensitivity C-reactive protein) and BNP

  6. Change in microbiota composition [ Time Frame: Three months ]
    The effect of intervention on gut microbiome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 BERRY trial
  • A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)

Information from the National Library of Medicine

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): NCT03620266


Contacts
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Contact: Ole Frobert, Prof +46 19 602 543 ole.frobert@regionorebrolan.se
Contact: Cecilia Bergh, PhD +46 730 68 28 92 cecilia.bergh@regionorebrolan.se

Locations
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Sweden
Department of Cardiology, Skånes universitetssjukhus
Lund, Sweden, 221 00
Cardiology Clinic, Västmanlands sjukhus Not yet recruiting
Västerås, Sweden, 721 89
Contact: Amra Kåregren, MD    +46 21 17 52 04    amra.karegren@ltv.se   
Department of Cardiology, Örebro University Hospital Not yet recruiting
Örebro, Sweden, 701 85
Contact: Ole Frobert, prof    +46 19 602 54 13    ole.frobert@regionorebrolan.se   
Contact: Cecilia Bergh, PhD    +46 730 68 28 92    cecilia.bergh@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Region Västmanland
Region Skane
Chalmers University of Technology
Investigators
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Study Director: Ole Frobert, Prof Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden
Principal Investigator: Cecilia Bergh, PhD Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden

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Responsible Party: Ole Frobert, MD, PhD, Professor, Region Örebro County
ClinicalTrials.gov Identifier: NCT03620266     History of Changes
Other Study ID Numbers: BERRY 3.0
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ole Frobert, MD, PhD, Region Örebro County:
AMI, anthocyanin, bilberry, exercise capacity, cholesterol
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases