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

Not Applicable

Completed

• Conditions: Inflammation; Heart Failure; Sudden Cardiac Death
• Interventions: Dietary Supplement: beverage without polyphenols; Dietary Supplement: polyphenols (non-alcoholic beer)

• Registration Number: NCT00933218
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Status Verified: 2009-07
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beverage without polyphenols	beverage without polyphenols	-
polyphenols (non-alcoholic beer)	polyphenols (non-alcoholic beer)	-

Primary Outcome Measures

Name	Time	Method
Inflammatory marker: Interleukin 6 and Interleukin 10	pre-, post-, one & three day follow-up

Secondary Outcome Measures

Name	Time	Method
E/E' ratio	pre-, post-, one & three day follow-up
AV-ratio	pre-, post-, one & three day follow-up

Trial Locations

Locations (1)

Department of Prevention and Sports medicine; 🇩🇪 Munich, Bavaria, Germany