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

Heart Failure Clinical Trial

— Be-MaGIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933218
• Other study ID #: 2384/09
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: October 19, 2010
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Failure
• Inflammation
• Sudden Cardiac Death

Intervention

Dietary Supplement:
• polyphenols (non-alcoholic beer)
1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run
• 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

Locations

Country	Name	City	State
Germany	Department of Prevention and Sports medicine	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker: Interleukin 6 and Interleukin 10		pre-, post-, one & three day follow-up	Yes
Secondary	E/E' ratio		pre-, post-, one & three day follow-up	No
Secondary	AV-ratio		pre-, post-, one & three day follow-up	No