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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run

Conditions
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Inflammation, Heart Failure, Sudden Cardiac Death

Intervention / Treatment
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* Dietary Supplement: polyphenols (non-alcoholic beer)
* Dietary Supplement: beverage without polyphenols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyphenols (non-alcoholic beer)<br> | Dietary Supplement: polyphenols (non-alcoholic beer)<br>* 1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run<br>|
| Placebo Comparator: beverage without polyphenols<br> | Dietary Supplement: beverage without polyphenols<br>* 1.0 - 1.5 l of beverage without polyphenols (otherwise the same composition as non-alcoholic beer) per day; 3 weeks before and during a marathon run<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker: Interleukin 6 and Interleukin 10 |  | pre-, post-, one & three day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E/E' ratio |  | pre-, post-, one & three day follow-up | 
| AV-ratio |  | pre-, post-, one & three day follow-up |