Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial (Be-MaGIC)
|ClinicalTrials.gov Identifier: NCT00933218|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : October 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Heart Failure Sudden Cardiac Death||Dietary Supplement: polyphenols (non-alcoholic beer) Dietary Supplement: beverage without polyphenols||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
|Active Comparator: polyphenols (non-alcoholic beer)||
Dietary Supplement: polyphenols (non-alcoholic beer)
1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run
|Placebo Comparator: beverage without polyphenols||
Dietary Supplement: beverage without polyphenols
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
- Inflammatory marker: Interleukin 6 and Interleukin 10 [ Time Frame: pre-, post-, one & three day follow-up ]
- E/E' ratio [ Time Frame: pre-, post-, one & three day follow-up ]
- AV-ratio [ Time Frame: pre-, post-, one & three day follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933218
|Department of Prevention and Sports medicine|
|Munich, Bavaria, Germany, 80809|