Clinical trial NCT03620266: Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
Official title: Effects of Bilberry and Oat Intake on Plasma Lipid Profile, Inflammation, and Exercise Capacity in Patients With Type 2 Diabetes and/or Myocardial Infarction (BioDiaMI): a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: acute myocardial infarction
diet therapy
anthocyanin
bilberry bush
exercise capacity
cholesterol
beta glucans
type 2 diabetes mellitus
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Region Västmanland
name: Region Skane
name: Chalmers University of Technology
name: Värmland County Council, Sweden
name: Vastra Gotaland Region
name: Aarhus University Hospital
name: Odense University Hospital
name: Falu Hospital
First posted: 2018-08-08
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for patients with manifest chronic cardiometabolic disease, such as type 2 diabets mellitus (T2DM) and myocardial infarction (MI). However, 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, for patients diagnosed with T2DM and/or MI. 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, glycaemia, and gut microbiota composition after three months.

Implications:

Secondary prevention after cardiometabolic disease, including T2DM and MI, has improved during the last decades but diabetes complications, readmissions and cadiovascular related deaths following these conditions remain large health care challenges. Controlling hyperlipidemia, hyperglycaemia, hypertension 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 in high-risk patients or risk prevention in subjects with T2DM.


Eligibility criteria: Inclusion criteria

* Confirmed T2DM diagnosis (any treatment modality accepted) and/or within 3 years post STEMI or NSTEMI
* Completed coronary angiography/PCI
* Male and female subjects ≥18 years
* Allocated to atorvastatin at a daily dose of 80 mg (only eligible for patients enrolled up to 7 days post MI and not for T2D subjects)
* 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 BioDiaMI trial
* Inability to provide informed consent

Primary outcomes:
measure: Plasma levels of LDL cholesterol
timeFrame: Three months
Secondary outcomes:
measure: Plasma lipid profile
timeFrame: Three months
measure: Symptom-limited bicycle ergometer test
timeFrame: Three months
measure: Dynamic unilateral heel-lft and unilateral shoulder flexion tests
timeFrame: Three months
measure: Self-reported physical activity level
timeFrame: Three months
measure: Plasma concentrations of inflammatory and heart function markers
timeFrame: Three months
measure: Plasma concentrations of other biochemical markers
timeFrame: Three months
measure: Untargeted plasma metabolome
timeFrame: Three months
measure: Fecal samples of gut microbiota composition
timeFrame: Three months
measure: Left ventricular systolic function
timeFrame: Three months
measure: Resting heart rate
timeFrame: Three months
measure: Systolic and diastolic blood pressure
timeFrame: Three months
measure: Urine albumin-creatinine ratio
timeFrame: Three months
measure: Continuous glucose monitoring with Continuous Glucose Monitors (CGM) - FreeStyle model 2
timeFrame: Three months
measure: Body composition with multi-frequency biothesiometry
timeFrame: Three months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes center
city: Odense
country: Denmark
facility: Odense University Hospital
city: Falun
country: Sweden
facility: Falu lasarett
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Karlstad
country: Sweden
facility: Karlstad general hospital
city: Lund
country: Sweden
facility: Department of Cardiology, Skånes universitetssjukhus
city: Västerås
country: Sweden
facility: Cardiology Clinic, Västmanlands sjukhus
city: Örebro
country: Sweden
facility: Department of Cardiology, Örebro University Hospital
Study officials:
affiliation: Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden
name: Ole Frobert, Prof
role: STUDY_DIRECTOR
affiliation: Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden
name: Cecilia Bergh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.