Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
- Conditions
- Myocardial Infarction
- Interventions
- Dietary Supplement: BilberryDietary Supplement: Bioprocessed oat branDietary Supplement: PlaceboDietary Supplement: Combination bilberry/oats
- Registration Number
- NCT03620266
- Lead Sponsor
- Ole Frobert, MD, PhD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilberry Bilberry 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. Bioprocessed oat bran Bioprocessed oat bran 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. Reference/Placebo Placebo 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. Combination of oat and bilberry Combination bilberry/oats 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.
- Primary Outcome Measures
Name Time Method Plasma levels of LDL cholesterol Three months The effect of intervention on difference between the groups of LDL cholesterol after three months
- Secondary Outcome Measures
Name Time Method Symptom-limited bicycle ergometer test Three months The effect of intervention on exercise capacity (measured as maximal workload in Watts and as estimated maximal oxygen uptake (VO2 max))
Self-reported physical activity level 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)
Plasma concentrations of other biochemical markers Three months The effect if intervention on plasma concentrations of biochemical markers of insulin, creatinine, Cystatin C, glucose and C-peptide
Urine albumin-creatinine ratio Three months Urine albumin-creatinine ratio will be measured for for T2DM only
Body composition with multi-frequency biothesiometry Three months Body composition willbe measured with multi-frequency biothesiometry (for T2DM only)
Fecal samples of gut microbiota composition Three months 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 Three months 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
Systolic and diastolic blood pressure Three months The effect of intervention on blood pressure (mmHg)
Continuous glucose monitoring with Continuous Glucose Monitors (CGM) - FreeStyle model 2 Three months Continuous glucose monitoring (in a subset of T2DM only, n=80 in total)
Plasma lipid profile Three months 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.
Plasma concentrations of inflammatory and heart function markers Three months 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).
Resting heart rate Three months The effect of intervention on resting heart rate
Dynamic unilateral heel-lft and unilateral shoulder flexion tests Three months The effect of intervention on muscle endurance
Untargeted plasma metabolome Three months 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.
Trial Locations
- Locations (8)
Odense University Hospital
🇩🇰Odense, Denmark
Steno Diabetes center
🇩🇰Aarhus, Denmark
Falu lasarett
🇸🇪Falun, Sweden
Karlstad general hospital
🇸🇪Karlstad, Sweden
Sahlgrenska Universitetssjukhuset
🇸🇪Gothenburg, Sweden
Cardiology Clinic, Västmanlands sjukhus
🇸🇪Västerås, Sweden
Department of Cardiology, Skånes universitetssjukhus
🇸🇪Lund, Sweden
Department of Cardiology, Örebro University Hospital
🇸🇪Örebro, Sweden