Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00933218
Status:
COMPLETED
Last Update Posted:
2010-10-20
First Post:
2009-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D001628', 'term': 'Beverages'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-19', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory marker: Interleukin 6 and Interleukin 10', 'timeFrame': 'pre-, post-, one & three day follow-up'}], 'secondaryOutcomes': [{'measure': "E/E' ratio", 'timeFrame': 'pre-, post-, one & three day follow-up'}, {'measure': 'AV-ratio', 'timeFrame': 'pre-, post-, one & three day follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Heart Failure', 'Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '32704381', 'type': 'DERIVED', '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.'}, {'pmid': '31154595', 'type': 'DERIVED', '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.'}, {'pmid': '29370708', 'type': 'DERIVED', '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.'}, {'pmid': '22543737', 'type': 'DERIVED', '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.'}, {'pmid': '21448080', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders.\n\nAerobic 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.\n\nWe 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.\n\nDiagnostic tools include measurements of microvasculature, the large vessels and echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and interleukins.\n\nAll variations are analysed on the basis of consumption of polyphenols as they are found in in hops (Humulus lupus L.) and beer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men aged 20-60 years\n\nExclusion Criteria:\n\n* manifested heart disease\n* insulin dependent diabetes mellitus\n* multi drug therapy\n* GFR \\< 60 ml/min\n* smokers\n* neoplasia\n* (former) alcoholism\n* known malabsorption\n* known chronic inflammatory disease'}, 'identificationModule': {'nctId': 'NCT00933218', 'acronym': 'Be-MaGIC', 'briefTitle': 'Beer, Marathon, Genetics, Inflammation and the Cardiovascular System: Be-MaGIC-Trial', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run', 'orgStudyIdInfo': {'id': '2384/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'polyphenols (non-alcoholic beer)', 'interventionNames': ['Dietary Supplement: polyphenols (non-alcoholic beer)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'beverage without polyphenols', 'interventionNames': ['Dietary Supplement: beverage without polyphenols']}], 'interventions': [{'name': 'polyphenols (non-alcoholic beer)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.0 - 1.5 l non-alcoholic beer per day; 3 weeks before and during a marathon run', 'armGroupLabels': ['polyphenols (non-alcoholic beer)']}, {'name': 'beverage without polyphenols', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['beverage without polyphenols']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80809', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Prevention and Sports medicine', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Praev. & Rehab. Sports medicine; Klinikum r. d. Isar; contact person: Mr. Johannes Scherr, MD'}}}}