Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial (Be-MaGIC)
Primary Purpose
Inflammation, Heart Failure, Sudden Cardiac Death
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
polyphenols (non-alcoholic beer)
beverage without polyphenols
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
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
Sites / Locations
- Department of Prevention and Sports medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
polyphenols (non-alcoholic beer)
beverage without polyphenols
Arm Description
Outcomes
Primary Outcome Measures
Inflammatory marker: Interleukin 6 and Interleukin 10
Secondary Outcome Measures
E/E' ratio
AV-ratio
Full Information
NCT ID
NCT00933218
First Posted
June 29, 2009
Last Updated
October 19, 2010
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00933218
Brief Title
Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial
Acronym
Be-MaGIC
Official Title
Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Heart Failure, Sudden Cardiac Death
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polyphenols (non-alcoholic beer)
Arm Type
Active Comparator
Arm Title
beverage without polyphenols
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
polyphenols (non-alcoholic beer)
Intervention Description
1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run
Intervention Type
Dietary Supplement
Intervention Name(s)
beverage without polyphenols
Intervention Description
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
Primary Outcome Measure Information:
Title
Inflammatory marker: Interleukin 6 and Interleukin 10
Time Frame
pre-, post-, one & three day follow-up
Secondary Outcome Measure Information:
Title
E/E' ratio
Time Frame
pre-, post-, one & three day follow-up
Title
AV-ratio
Time Frame
pre-, post-, one & three day follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Prevention and Sports medicine
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80809
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
32704381
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.
Results Reference
derived
PubMed Identifier
31154595
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.
Results Reference
derived
PubMed Identifier
29370708
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.
Results Reference
derived
PubMed Identifier
22543737
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.
Results Reference
derived
PubMed Identifier
21448080
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.
Results Reference
derived
Learn more about this trial
Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial
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