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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933218
First Posted: July 7, 2009
Last Update Posted: October 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  Purpose
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.

Condition Intervention
Inflammation Heart Failure Sudden Cardiac Death Dietary Supplement: polyphenols (non-alcoholic beer) Dietary Supplement: beverage without polyphenols

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Inflammatory marker: Interleukin 6 and Interleukin 10 [ Time Frame: pre-, post-, one & three day follow-up ]

Secondary Outcome Measures:
  • E/E' ratio [ Time Frame: pre-, post-, one & three day follow-up ]
  • AV-ratio [ Time Frame: pre-, post-, one & three day follow-up ]

Estimated Enrollment: 250
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: polyphenols (non-alcoholic beer) Dietary Supplement: 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 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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933218


Locations
Germany
Department of Prevention and Sports medicine
Munich, Bavaria, Germany, 80809
Sponsors and Collaborators
Technische Universität München
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Praev. & Rehab. Sports medicine; Klinikum r. d. Isar; contact person: Mr. Johannes Scherr, MD
ClinicalTrials.gov Identifier: NCT00933218     History of Changes
Other Study ID Numbers: 2384/09
First Submitted: June 29, 2009
First Posted: July 7, 2009
Last Update Posted: October 20, 2010
Last Verified: July 2009

Additional relevant MeSH terms:
Heart Failure
Inflammation
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden