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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00933218
First received: June 29, 2009
Last updated: October 19, 2010
Last verified: July 2009
  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: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • E/E' ratio [ Time Frame: pre-, post-, one & three day follow-up ] [ Designated as safety issue: No ]
  • AV-ratio [ Time Frame: pre-, post-, one & three day follow-up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933218

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

No publications provided by Technische Universität München

Additional 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
Study First Received: June 29, 2009
Last Updated: October 19, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 29, 2014