Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial

Technical University of Munich

Status: Completed

Conditions: Inflammation; Heart Failure; Sudden Cardiac Death

Treatments: Dietary Supplement: beverage without polyphenols; Dietary Supplement: polyphenols (non-alcoholic beer)

Study type: Interventional

Funder types: Other

Identifiers

NCT00933218

2384/09

Details and patient eligibility

About

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. The investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. Furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Full description

Regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders.

Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of microvasculature, the large vessels and echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and interleukins.

All variations are analysed on the basis of consumption of polyphenols as they are found in in hops (Humulus lupus L.) and beer.

Enrollment: 250 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• men aged 20-60 years

Exclusion criteria

• manifested heart disease
• insulin dependent diabetes mellitus
• multi drug therapy
• GFR < 60 ml/min
• smokers
• neoplasia
• (former) alcoholism
• known malabsorption
• known chronic inflammatory disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

250 participants in 2 patient groups, including a placebo group

polyphenols (non-alcoholic beer)

Active Comparator group

Treatment:

Dietary Supplement: polyphenols (non-alcoholic beer)

beverage without polyphenols

Placebo Comparator group

Treatment:

Dietary Supplement: beverage without polyphenols