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

Sponsored by:	Technische Universität München
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00933218

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:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Dietary Supplements Diets Heart Failure

U.S. FDA Resources

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
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
polyphenols (non-alcoholic beer): Active Comparator	Dietary Supplement: polyphenols (non-alcoholic beer) 1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run
beverage without polyphenols: Placebo Comparator	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

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

Contacts

Contact: Johannes C Scherr, MD

+49 89289 ext 24414

scherr@sport.med.tum.de

Locations

Germany, Bavaria
Department of Prevention and Sports medicine	Recruiting
Munich, Bavaria, Germany, 80809
Contact: Johannes C Scherr, MD +49 89 289 ext 24414 scherr@sport.med.tum.de
Contact: Martin Halle, Prof., MD +49 89 289 ext 24431 halle@sport.med.tum.de
Principal Investigator: Johannes C Scherr, MD

Sponsors and Collaborators

Technische Universität München

More Information

Additional Information:

homepage of the realizing institution This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	( Praev. & Rehab. Sports medicine; Klinikum r. d. Isar; contact person: Mr. Johannes Scherr, MD )
Study ID Numbers:	2384/09
Study First Received:	June 29, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933218 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Death
Heart Failure
Heart Diseases
Death, Sudden

Heart Arrest
Death, Sudden, Cardiac
Inflammation

Additional relevant MeSH terms:

Death
Heart Failure
Pathologic Processes
Heart Diseases
Death, Sudden

Heart Arrest
Cardiovascular Diseases
Death, Sudden, Cardiac
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009