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

NCT ID: NCT00933218

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Inflammation Heart Failure Sudden Cardiac Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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polyphenols (non-alcoholic beer)

Group Type ACTIVE_COMPARATOR

polyphenols (non-alcoholic beer)

Intervention Type DIETARY_SUPPLEMENT

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

beverage without polyphenols

Group Type PLACEBO_COMPARATOR

beverage without polyphenols

Intervention Type 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

Interventions

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polyphenols (non-alcoholic beer)

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Locations

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Department of Prevention and Sports medicine

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32704381 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31154595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29370708 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22543737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21448080 (View on PubMed)

Other Identifiers

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2384/09

Identifier Type: -

Identifier Source: org_study_id