Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT01662232
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2012-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Endothelial Function by EGCG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2012-08-07', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated dilation of the arteria brachialis', 'timeFrame': '2 hours after ingestion', 'description': 'Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.'}], 'secondaryOutcomes': [{'measure': 'Agonist-induced platelet aggregation in vitro', 'timeFrame': '2 hours after ingestion', 'description': 'Blood is drawn two hours after consumption and the effects on in vitro agonist-induced platelet aggregation after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG are measured.'}, {'measure': 'Determination of plasma tea polyphenol levels', 'timeFrame': '2 hours after ingestion', 'description': 'Blood is drawn two hours after consumption and plasma concentrations of tea polyphenols are measured after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG by HPLC.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Green tea', 'EGCG', 'Cardiovascular diseases', 'Endothelial function', 'Flow-mediated dilation'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.\n\nTea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.\n\nIn this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male healthy volunteers\n* 20-50 years\n* BMI \\< 27 kg/m2\n* Cholesterol \\< 240 mg/dl\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Hypertension\n* Conditions with impaired endothelial function\n* Smoking\n* Regular drug use\n* Alcohol abuse\n* Regular tea drinkers'}, 'identificationModule': {'nctId': 'NCT01662232', 'briefTitle': 'Improvement of Endothelial Function by EGCG', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Char-EGCG-FMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Green tea beverage', 'description': '200 mg EGCG as green tea beverage.', 'interventionNames': ['Dietary Supplement: Green tea beverage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Green tea extract', 'description': '200 mg EGCG as green tea extract and same volume water as for tea beverage.', 'interventionNames': ['Dietary Supplement: Green tea extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epigallocatechin-3-gallate (EGCG)', 'description': '200 mg EGCG and same volume water as for tea beverage.', 'interventionNames': ['Dietary Supplement: EGCG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Water)', 'description': 'Same volume water as for all intervention arms.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Green tea beverage', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Green tea beverage']}, {'name': 'Green tea extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Green tea extract']}, {'name': 'EGCG', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Epigallocatechin-3-gallate (EGCG)']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo (Water)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Mario Lorenz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Mario Lorenz, PhD', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}