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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- LDL cholesterol [ Time Frame: Three months ]The effect of intervention on levels of LDL cholesterol at three months
- Symptom-limited bicycle ergometer test [ Time Frame: Three months ]The effect of intervention on exercise capacity
- Dynamic unilateral heel-lft and unilateral shoulder flexion tests [ Time Frame: Three months ]The effect of intervention on muscle endurance
- 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)
- Fasting lipid levels [ Time Frame: Three months ]The effect of intervention on TG (total cholesterol), HDL cholesterol and TGA (triglycerides).
- Inflammatory markers [ Time Frame: Three months ]The effect of intervention on HbA1c (glycosylated hemoglobin), hs_CRP (high sensitivity C-reactive protein) and BNP
- Change in microbiota composition [ Time Frame: Three months ]The effect of intervention on gut microbiome
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
|Contact: Ole Frobert, Prof||+46 19 602 firstname.lastname@example.org|
|Contact: Cecilia Bergh, PhD||+46 730 68 28 email@example.com|
|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 firstname.lastname@example.org|
|Department of Cardiology, Örebro University Hospital||Not yet recruiting|
|Örebro, Sweden, 701 85|
|Contact: Ole Frobert, prof +46 19 602 54 13 email@example.com|
|Contact: Cecilia Bergh, PhD +46 730 68 28 92 firstname.lastname@example.org|
|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|