Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI

NCT03620266 | Active Not Recruiting DMC

• 1 other identifier: BioDiaMI
• Study Type: interventional
• Target: 900
• Locations: 2 countries
• Sites: 8

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.

Conditions

Myocardial Infarction

Keywords

acute myocardial infarction; diet therapy; anthocyanin; bilberry bush; exercise capacity; cholesterol; beta glucans; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Plasma levels of LDL cholesterol

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

  Three months

Secondary Outcomes (33)

• Plasma lipid profile

  Three months

• Symptom-limited bicycle ergometer test

  Three months

• Dynamic unilateral heel-lft and unilateral shoulder flexion tests

  Three months

• Self-reported physical activity level

  Three months

• Plasma Cardiac Troponin Concentration

  Three months

Study Arms (4)

Bilberry

EXPERIMENTAL

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: Bilberry

Reference/Placebo

PLACEBO COMPARATOR

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: Placebo

Bioprocessed oat bran

EXPERIMENTAL

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: Bioprocessed oat bran

Combination of oat and bilberry

EXPERIMENTAL

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.

Dietary Supplement: Combination bilberry/oats

Interventions

Bioprocessed oat bran DIETARY_SUPPLEMENT

The dietary intervention 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.

Bioprocessed oat bran

Combination bilberry/oats DIETARY_SUPPLEMENT

The dietary intervention 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.

Combination of oat and bilberry

Bilberry DIETARY_SUPPLEMENT

The dietary intervention will 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.

Bilberry

Placebo DIETARY_SUPPLEMENT

The dietary intervention 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.

Reference/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ole Frobert, MD, PhD: lead
• Region Västmanland: collaborator
• Region Skane: collaborator
• Chalmers University of Technology: collaborator
• Värmland County Council, Sweden: collaborator
• Vastra Gotaland Region: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Falu Hospital: collaborator

Study Sites (8)

Steno Diabetes center

Aarhus, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Falu lasarett

Falun, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Karlstad general hospital

Karlstad, Sweden

Location

Department of Cardiology, Skånes universitetssjukhus

Lund, 221 00, Sweden

Location

Department of Cardiology, Örebro University Hospital

Örebro, 701 85, Sweden

Location

Cardiology Clinic, Västmanlands sjukhus

Västerås, 721 89, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33971938 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Diabetes Mellitus, Type 2

Interventions

Vaccinium myrtillus extract

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ole Frobert, Prof

  Department of Cardiology, Örebro Univerity Hospital, 701 85 Örebro, Sweden

  STUDY DIRECTOR

• Cecilia Bergh, PhD

  Clinical Epidemiology and Biostatistics, School of medical Sciences, örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 8, 2018
• Study Start: September 30, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); SE (6)