Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial (Be-MaGIC)
October 19, 2010 updated by: Technical University of Munich
Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bavaria
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Munich, Bavaria, Germany, 80809
- Department of Prevention and Sports medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Inflammatory marker: Interleukin 6 and Interleukin 10
Time Frame: pre-, post-, one & three day follow-up
|
pre-, post-, one & three day follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
E/E' ratio
Time Frame: pre-, post-, one & three day follow-up
|
pre-, post-, one & three day follow-up
|
|
AV-ratio
Time Frame: pre-, post-, one & three day follow-up
|
pre-, post-, one & three day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
July 6, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
October 20, 2010
Last Update Submitted That Met QC Criteria
October 19, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2384/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.