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
Abstract 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 bene...
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doaj-a1330500680e452c96b03559dd2331612021-05-11T14:55:49ZengBMCTrials1745-62152021-05-0122111110.1186/s13063-021-05287-5Effects 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 trialCecilia Bergh0Rikard Landberg1Kristina Andersson2Lovisa Heyman-Lindén3Ana Rascón4Anders Magnuson5Payam Khalili6Amra Kåregren7Johan Nilsson8Carlo Pirazzi9David Erlinge10Ole Fröbert11Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro UniversityDepartment of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of TechnologyDepartment of Experimental Medical Science, Lund UniversityMolecular Nutrition, Department of Experimental Medical Science, Lund UniversityGlucanova ABClinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro UniversityDepartment of Cardiology and Acute Internal Medicine, Central HospitalDepartment of Medicine, Hospital Region VästmanlandDepartment of Public Health and Clinical Medicine, Umeå UniversityDepartment of Cardiology, Sahlgrenska University HospitalDepartment of Cardiology, Clinical Sciences, Lund UniversityDepartment of Cardiology, Faculty of Medicine and Health, Örebro UniversityAbstract 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. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI. Methods The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months. Discussion 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. Trial registration ClinicalTrials.gov NCT03620266 . Registered on August 8, 2018.https://doi.org/10.1186/s13063-021-05287-5AnthocyaninAnthocyanin-derived phenolic acid metabolitesBilberryCholesterolDiet therapyExercise test |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Cecilia Bergh Rikard Landberg Kristina Andersson Lovisa Heyman-Lindén Ana Rascón Anders Magnuson Payam Khalili Amra Kåregren Johan Nilsson Carlo Pirazzi David Erlinge Ole Fröbert |
spellingShingle |
Cecilia Bergh Rikard Landberg Kristina Andersson Lovisa Heyman-Lindén Ana Rascón Anders Magnuson Payam Khalili Amra Kåregren Johan Nilsson Carlo Pirazzi David Erlinge Ole Fröbert 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 Anthocyanin Anthocyanin-derived phenolic acid metabolites Bilberry Cholesterol Diet therapy Exercise test |
author_facet |
Cecilia Bergh Rikard Landberg Kristina Andersson Lovisa Heyman-Lindén Ana Rascón Anders Magnuson Payam Khalili Amra Kåregren Johan Nilsson Carlo Pirazzi David Erlinge Ole Fröbert |
author_sort |
Cecilia Bergh |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-05-01 |
description |
Abstract 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. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI. Methods The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months. Discussion 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. Trial registration ClinicalTrials.gov NCT03620266 . Registered on August 8, 2018. |
topic |
Anthocyanin Anthocyanin-derived phenolic acid metabolites Bilberry Cholesterol Diet therapy Exercise test |
url |
https://doi.org/10.1186/s13063-021-05287-5 |
work_keys_str_mv |
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