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NCT Number: NCT00933218

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

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.

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Key information

Conditions

Inflammation Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prevention and Sports medicine

Munich, Bavaria, 80809, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyphenols (non-alcoholic beer)

Dietary Supplement

1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run

beverage without polyphenols

Dietary Supplement

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

Primary outcomes

  1. Inflammatory marker: Interleukin 6 and Interleukin 10

    Time frame: pre-, post-, one & three day follow-up

Secondary outcomes

  1. E/E' ratio

    Time frame: pre-, post-, one & three day follow-up

  2. AV-ratio

    Time frame: pre-, post-, one & three day follow-up

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: Be-MaGIC

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 7, 2009
Registry last updated
Oct 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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