Clinical trial NCT00933218: Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial
Official title: Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Heart Failure
Sudden Cardiac Death
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 250
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory marker: Interleukin 6 and Interleukin 10
timeFrame: pre-, post-, one & three day follow-up
Secondary outcomes:
measure: E/E' ratio
timeFrame: pre-, post-, one & three day follow-up
measure: AV-ratio
timeFrame: pre-, post-, one & three day follow-up
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Prevention and Sports medicine
state: Bavaria
Study officials:
References:
citation: Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.
citation: Roeh A, Schuster T, Jung P, Schneider J, Halle M, Scherr J. Two dimensional and real-time three dimensional ultrasound measurements of left ventricular diastolic function after marathon running: results from a substudy of the BeMaGIC trial. Int J Cardiovasc Imaging. 2019 Oct;35(10):1861-1869. doi: 10.1007/s10554-019-01634-5. Epub 2019 Jun 1.
citation: Scherr J, Halle M. Amendment on the findings of two previously published articles. Eur J Prev Cardiol. 2018 Mar;25(5):558. doi: 10.1177/2047487317754279. Epub 2018 Jan 26. No abstract available.
citation: Scherr J, Schuster T, Pressler A, Roeh A, Christle J, Wolfarth B, Halle M. Repolarization perturbation and hypomagnesemia after extreme exercise. Med Sci Sports Exerc. 2012 Sep;44(9):1637-43. doi: 10.1249/MSS.0b013e318258aaf4.
citation: Scherr J, Braun S, Schuster T, Hartmann C, Moehlenkamp S, Wolfarth B, Pressler A, Halle M. 72-h kinetics of high-sensitive troponin T and inflammatory markers after marathon. Med Sci Sports Exerc. 2011 Oct;43(10):1819-27. doi: 10.1249/MSS.0b013e31821b12eb.