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Effects of Bilberry and Oat Intake After AMI (BIOAMI)

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bilberry
Placebo
Bioprocessed oat bran
Combination bilberry/oats
Sponsored by
Ole Frobert, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring acute myocardial infarction, diet therapy, anthocyanin, bilberry bush, exercise capacity, cholesterol, beta glucans

Eligibility Criteria

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

Inclusion criteria

  • STEMI or NSTEMI
  • Completed coronary angiography/PCI
  • Male and female subjects ≥18 years
  • Allocated to atorvastatin at a daily dose of 80 mg
  • Written informed consent

Exclusion criteria

  • Emergency coronary artery bypass grafting
  • <18 years of age
  • LDL cholesterol <2.0 mmol/L
  • Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of >15 g of oatmeal or equivalent
  • Food allergy/intolerance to gluten, bilberries or legumes
  • Previous randomization in the BIOAMI trial
  • Inability to provide informed consent

Sites / Locations

  • Sahlgrenska UniversitetssjukhusetRecruiting
  • Karlstad general hospitalRecruiting
  • Department of Cardiology, Skånes universitetssjukhusRecruiting
  • Cardiology Clinic, Västmanlands sjukhusRecruiting
  • Department of Cardiology, Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Bilberry

Reference/Placebo

Bioprocessed oat bran

Combination of oat and bilberry

Arm Description

Dietary supplement with bilberry shakes 2 times daily for 3 months (containing in total 40g of dried bilberry powder equalling 480 g of fresh berries per day). Product development in collaboration with Glucanova AB.

Dietary supplement with reference shakes 2 times daily for 3 months (containing no active bilberry or no active oats, but with similar texture and taste as both bilberry and oat). Product development in collaboration with Glucanova AB.

Dietary supplement with bioprocessed oat bran shakes 2 times daily for 3 months (containing beta glucans from the Glucanova® technology, invented by Glucanova AB).Product development in collaboration with Glucanova AB.

Dietary supplement with a combination of bioprocessed oat bran and dried bilberry (shakes) 2 times daily for 3 months. Product development in collaboration with Glucanova AB.

Outcomes

Primary Outcome Measures

Plasma levels of LDL cholesterol
The effect of intervention on difference between the groups of LDL cholesterol after three months

Secondary Outcome Measures

Plasma lipid profile
The effect of intervention on differences between the groups of fasting lipid profile including HDL, triglycerides, total cholesterol, small-dense LDL cholesterol, apo A, apo B, Lp(a) and oxidized LDL.
Symptom-limited bicycle ergometer test
The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))
Dynamic unilateral heel-lft and unilateral shoulder flexion tests
The effect of intervention on muscle endurance
Self-reported physical activity level
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)
Plasma concentrations of inflammatory and heart function markers
The effect of intervention on plasma concentrations of biochemical markers of troponin, NT-proBNP, hs_CRP (high sensitivity C-reactive protein), IL-6 and HbA1c (glycosylated hemoglobin).
Plasma concentrations of other biochemical markers
The effect if intervention on plasma concentrations of biochemical markers of insulin, creatinine, Cystatin C, glucose and C-peptide
Untargeted plasma metabolome
Untargeted plasma metabolomics will be employed to exploratively assess alterations in endogenous and exposome-related metabolites and to identify metabolites that may differ with treatment.
Fecal samples of gut microbiota composition
These exploratory analyses of will allow to investigate the extent to which gut microbiota composition and activity differs between responders and non-responders to the interventions.
Left ventricular systolic function
The effect of intervention on left ventricular function. Baseline left ventricular systolic function, expressed as global ejection fraction in percent according to the biplane Simpson method, will be evaluated by echocardiography by the discharging physician. The procedure will be repeated after three months by an experienced echocardiography technician blinded to results of the initial examinations
Resting heart rate
The effect of intervention on resting heart rate
Systolic and diastolic blood pressure
The effect of intervention on blood pressure (mmHg)

Full Information

First Posted
August 2, 2018
Last Updated
September 6, 2023
Sponsor
Ole Frobert, MD, PhD
Collaborators
Region Västmanland, Region Skane, Chalmers University of Technology, Region Västerbotten, Värmland County Council, Sweden, Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT03620266
Brief Title
Effects of Bilberry and Oat Intake After AMI
Acronym
BIOAMI
Official Title
Effects of Bilberry and Oat Intake on Lipids, Inflammation, and Exercise Capacity After Acute Myocardial Infarction (BIOAMI): a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ole Frobert, MD, PhD
Collaborators
Region Västmanland, Region Skane, Chalmers University of Technology, Region Västerbotten, Värmland County Council, Sweden, Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Design: This is a double-blind, randomized, placebo-controlled clinical trial. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry and with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within five days following percutaneous coronary intervention for AMI. Patients will be randomized 1:1:1:1 to a three-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after three months. The major secondary endpoint is exercise capacity at three months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics and gut microbiota composition after three months. Implications: Secondary prevention after AMI has improved during the last decades but readmissions and death following AMI remain large health care challenges. Controlling hyperlipidemia and inflammation is critical to preventing new cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention after AMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
acute myocardial infarction, diet therapy, anthocyanin, bilberry bush, exercise capacity, cholesterol, beta glucans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilberry
Arm Type
Experimental
Arm Description
Dietary supplement with bilberry shakes 2 times daily for 3 months (containing in total 40g of dried bilberry powder equalling 480 g of fresh berries per day). Product development in collaboration with Glucanova AB.
Arm Title
Reference/Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement with reference shakes 2 times daily for 3 months (containing no active bilberry or no active oats, but with similar texture and taste as both bilberry and oat). Product development in collaboration with Glucanova AB.
Arm Title
Bioprocessed oat bran
Arm Type
Experimental
Arm Description
Dietary supplement with bioprocessed oat bran shakes 2 times daily for 3 months (containing beta glucans from the Glucanova® technology, invented by Glucanova AB).Product development in collaboration with Glucanova AB.
Arm Title
Combination of oat and bilberry
Arm Type
Experimental
Arm Description
Dietary supplement with a combination of bioprocessed oat bran and dried bilberry (shakes) 2 times daily for 3 months. Product development in collaboration with Glucanova AB.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bilberry
Intervention Description
The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture as both oat and bilberry), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bioprocessed oat bran
Intervention Description
The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Combination bilberry/oats
Intervention Description
The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
Primary Outcome Measure Information:
Title
Plasma levels of LDL cholesterol
Description
The effect of intervention on difference between the groups of LDL cholesterol after three months
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Plasma lipid profile
Description
The effect of intervention on differences between the groups of fasting lipid profile including HDL, triglycerides, total cholesterol, small-dense LDL cholesterol, apo A, apo B, Lp(a) and oxidized LDL.
Time Frame
Three months
Title
Symptom-limited bicycle ergometer test
Description
The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))
Time Frame
Three months
Title
Dynamic unilateral heel-lft and unilateral shoulder flexion tests
Description
The effect of intervention on muscle endurance
Time Frame
Three months
Title
Self-reported physical activity level
Description
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)
Time Frame
Three months
Title
Plasma concentrations of inflammatory and heart function markers
Description
The effect of intervention on plasma concentrations of biochemical markers of troponin, NT-proBNP, hs_CRP (high sensitivity C-reactive protein), IL-6 and HbA1c (glycosylated hemoglobin).
Time Frame
Three months
Title
Plasma concentrations of other biochemical markers
Description
The effect if intervention on plasma concentrations of biochemical markers of insulin, creatinine, Cystatin C, glucose and C-peptide
Time Frame
Three months
Title
Untargeted plasma metabolome
Description
Untargeted plasma metabolomics will be employed to exploratively assess alterations in endogenous and exposome-related metabolites and to identify metabolites that may differ with treatment.
Time Frame
Three months
Title
Fecal samples of gut microbiota composition
Description
These exploratory analyses of will allow to investigate the extent to which gut microbiota composition and activity differs between responders and non-responders to the interventions.
Time Frame
Three months
Title
Left ventricular systolic function
Description
The effect of intervention on left ventricular function. Baseline left ventricular systolic function, expressed as global ejection fraction in percent according to the biplane Simpson method, will be evaluated by echocardiography by the discharging physician. The procedure will be repeated after three months by an experienced echocardiography technician blinded to results of the initial examinations
Time Frame
Three months
Title
Resting heart rate
Description
The effect of intervention on resting heart rate
Time Frame
Three months
Title
Systolic and diastolic blood pressure
Description
The effect of intervention on blood pressure (mmHg)
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria STEMI or NSTEMI Completed coronary angiography/PCI Male and female subjects ≥18 years Allocated to atorvastatin at a daily dose of 80 mg Written informed consent Exclusion criteria Emergency coronary artery bypass grafting <18 years of age LDL cholesterol <2.0 mmol/L Daily intake or the intent to initiate daily intake of bilberry in any form or daily intake of >15 g of oatmeal or equivalent Food allergy/intolerance to gluten, bilberries or legumes Previous randomization in the BIOAMI trial Inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ole Frobert, Prof
Phone
+46 19 602 543
Email
ole.frobert@regionorebrolan.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Bergh, PhD
Phone
+46 730 68 28 92
Email
cecilia.bergh@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Frobert, Prof
Organizational Affiliation
Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cecilia Bergh, PhD
Organizational Affiliation
Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Universitetssjukhuset
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Pirazzi, MD, PhD
Facility Name
Karlstad general hospital
City
Karlstad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Payam Khalili, MD, PhD
Facility Name
Department of Cardiology, Skånes universitetssjukhus
City
Lund
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ehrlinge, prof
Phone
tel:+46 46 17 25 97
Email
david.erlinge@med.lu.se
Facility Name
Cardiology Clinic, Västmanlands sjukhus
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amra Kåregren, MD
Phone
+46 21 17 52 04
Email
amra.karegren@ltv.se
Facility Name
Department of Cardiology, Örebro University Hospital
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Frobert, prof
Phone
+46 19 602 54 13
Email
ole.frobert@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Cecilia Bergh, PhD
Phone
+46 730 68 28 92
Email
cecilia.bergh@regionorebrolan.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33971938
Citation
Bergh C, Landberg R, Andersson K, Heyman-Linden L, Rascon A, Magnuson A, Khalili P, Karegren A, Nilsson J, Pirazzi C, Erlinge D, Frobert O. Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2021 May 10;22(1):338. doi: 10.1186/s13063-021-05287-5.
Results Reference
derived

Learn more about this trial

Effects of Bilberry and Oat Intake After AMI

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