Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 11:59 AM
Study NCT ID:
NCT00917735
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Green Tea and Reduction of Breast Cancer Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkurzer@umn.edu', 'phone': '612-624-9789', 'title': 'Dr. Mindy Kurzer', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We had limited success in recruiting minority populations.'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': "Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.", 'eventGroups': [{'id': 'EG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.', 'otherNumAtRisk': 538, 'otherNumAffected': 407, 'seriousNumAtRisk': 538, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.', 'otherNumAtRisk': 537, 'otherNumAffected': 391, 'seriousNumAtRisk': 537, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 235, 'numAffected': 235}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 184, 'numAffected': 184}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 216, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 217, 'numAffected': 217}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 154, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 144, 'numAffected': 144}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respitory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 122, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 122, 'numAffected': 122}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 69, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 77, 'numAffected': 77}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musuclar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 65, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 69, 'numAffected': 69}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 280, 'numAffected': 280}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 218, 'numAffected': 218}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Elevated ALT or AST enzyme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Motorcycle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acoustic Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diagnosis of Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 537, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mammographic Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'}], 'classes': [{'title': 'Percent mammographic density at baseline', 'categories': [{'measurements': [{'value': '22.71', 'groupId': 'OG000', 'lowerLimit': '21.39', 'upperLimit': '24.10'}, {'value': '21.84', 'groupId': 'OG001', 'lowerLimit': '20.59', 'upperLimit': '23.17'}]}]}, {'title': 'Percent mammographic density at month 12', 'categories': [{'measurements': [{'value': '22.09', 'groupId': 'OG000', 'lowerLimit': '20.77', 'upperLimit': '23.50'}, {'value': '21.13', 'groupId': 'OG001', 'lowerLimit': '19.88', 'upperLimit': '22.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Mammographic density at baseline and month 12'}, {'type': 'PRIMARY', 'title': 'Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'}], 'classes': [{'title': 'Circulating estrone at baseline', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '24.0'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '24.9'}]}]}, {'title': 'Circulating estrone at month 12', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '23.7'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '23.6'}]}]}, {'title': 'Circulating estradiol at baseline', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.8'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.1'}]}]}, {'title': 'Circulating estradiol at month 12', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '4.1'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.5'}]}]}, {'title': 'Circulating androstenedione at baseline', 'categories': [{'measurements': [{'value': '479.8', 'groupId': 'OG000', 'lowerLimit': '459.4', 'upperLimit': '501.2'}, {'value': '507.2', 'groupId': 'OG001', 'lowerLimit': '485.9', 'upperLimit': '529.5'}]}]}, {'title': 'Circulating androstenedione at month 12', 'categories': [{'measurements': [{'value': '468.8', 'groupId': 'OG000', 'lowerLimit': '450.2', 'upperLimit': '488.3'}, {'value': '479.5', 'groupId': 'OG001', 'lowerLimit': '460.6', 'upperLimit': '499.1'}]}]}, {'title': 'Circulating testosterone at baseline', 'categories': [{'measurements': [{'value': '151.0', 'groupId': 'OG000', 'lowerLimit': '142.7', 'upperLimit': '159.7'}, {'value': '161.6', 'groupId': 'OG001', 'lowerLimit': '152.8', 'upperLimit': '170.8'}]}]}, {'title': 'Circulating testosterone at month 12', 'categories': [{'measurements': [{'value': '158.1', 'groupId': 'OG000', 'lowerLimit': '149.9', 'upperLimit': '166.9'}, {'value': '155.1', 'groupId': 'OG001', 'lowerLimit': '147.1', 'upperLimit': '163.6'}]}]}, {'title': 'Circulating SHBG at baseline', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '71.3'}, {'value': '69.1', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '72.3'}]}]}, {'title': 'Circulating SHBG at month 12', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '72.0'}, {'value': '68.7', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '72.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12'}, {'type': 'PRIMARY', 'title': 'Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'}], 'classes': [{'title': 'Circulating IGF-1 at baseline', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '85.3', 'upperLimit': '89.8'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '90.5'}]}]}, {'title': 'Circulating IGF-1 at month 12', 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000', 'lowerLimit': '81.6', 'upperLimit': '85.8'}, {'value': '83.1', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '85.2'}]}]}, {'title': 'Circulating IGFBP-3 at baseline', 'categories': [{'measurements': [{'value': '2048.0', 'groupId': 'OG000', 'lowerLimit': '2008.9', 'upperLimit': '2088.0'}, {'value': '2047.6', 'groupId': 'OG001', 'lowerLimit': '2008.9', 'upperLimit': '2087.1'}]}]}, {'title': 'Circulating IGFBP-3 at month 12', 'categories': [{'measurements': [{'value': '2048.1', 'groupId': 'OG000', 'lowerLimit': '2008.0', 'upperLimit': '2089.1'}, {'value': '2040.7', 'groupId': 'OG001', 'lowerLimit': '2001.0', 'upperLimit': '2081.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and month 12', 'description': 'Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '538'}, {'groupId': 'FG001', 'numSubjects': '537'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '463'}, {'groupId': 'FG001', 'numSubjects': '474'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '63'}]}]}], 'recruitmentDetails': 'August 2009 through April 2013', 'preAssignmentDetails': 'Prior to randomization, participants went through a screening clinic visit in which anthropometric characteristics and blood pressure were measured. In addition, blood was drawn to assess catechol-O-methyltransferase (COMT) genotype, hepatic function, and serological markers of hepatitis B and C virus.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'BG000'}, {'value': '537', 'groupId': 'BG001'}, {'value': '1075', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Green Tea Extract', 'description': 'Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Placebo: Two placebo capsules twice daily after breakfast and dinner for one year'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '5.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '538', 'groupId': 'BG000'}, {'value': '537', 'groupId': 'BG001'}, {'value': '1075', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '1026', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '515', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1020', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '538', 'groupId': 'BG000'}, {'value': '537', 'groupId': 'BG001'}, {'value': '1075', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.5', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '164.3', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '163.9', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist-to-hip ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.83', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.83', 'spread': '0.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1075}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2009-06-08', 'resultsFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-25', 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mammographic Density', 'timeFrame': 'Baseline and month 12', 'description': 'Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.'}, {'measure': 'Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)', 'timeFrame': 'Baseline and month 12', 'description': 'Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.'}, {'measure': 'Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3', 'timeFrame': 'Baseline and month 12', 'description': 'Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Green tea', 'Breast cancer', 'Prevention', 'COMT genotype', 'EGCG (Epigallocatechin gallate)', 'Mammographic density', 'Reproductive hormones', 'IGF axis proteins', 'Oxidative stress'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '37011435', 'type': 'DERIVED', 'citation': 'Bathgate JR, Radler DR, Kurzer M, Samavat H. Green tea extract supplementation does not modify plasma concentration of F2-isoprostanes in women who are postmenopause: Findings from a randomized controlled trial. Nutr Res. 2023 May;113:29-38. doi: 10.1016/j.nutres.2023.03.001. Epub 2023 Mar 9.'}, {'pmid': '30926986', 'type': 'DERIVED', 'citation': 'Samavat H, Wu AH, Ursin G, Torkelson CJ, Wang R, Yu MC, Yee D, Kurzer MS, Yuan JM. Green Tea Catechin Extract Supplementation Does Not Influence Circulating Sex Hormones and Insulin-Like Growth Factor Axis Proteins in a Randomized Controlled Trial of Postmenopausal Women at High Risk of Breast Cancer. J Nutr. 2019 Apr 1;149(4):619-627. doi: 10.1093/jn/nxy316.'}, {'pmid': '28747487', 'type': 'DERIVED', 'citation': 'Arikawa AY, Samavat H, Gross M, Kurzer MS. Plasma F2-isoprostanes Are Positively Associated with Glycemic Load, but Inversely Associated with Dietary Polyunsaturated Fatty Acids and Insoluble Fiber in Postmenopausal Women. J Nutr. 2017 Sep;147(9):1693-1699. doi: 10.3945/jn.117.254631. Epub 2017 Jul 26.'}, {'pmid': '27806972', 'type': 'DERIVED', 'citation': 'Samavat H, Newman AR, Wang R, Yuan JM, Wu AH, Kurzer MS. Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2016 Dec;104(6):1671-1682. doi: 10.3945/ajcn.116.137075. Epub 2016 Nov 2.'}, {'pmid': '26701796', 'type': 'DERIVED', 'citation': 'Dostal AM, Arikawa A, Espejo L, Kurzer MS. Long-Term Supplementation of Green Tea Extract Does Not Modify Adiposity or Bone Mineral Density in a Randomized Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Feb;146(2):256-64. doi: 10.3945/jn.115.219238. Epub 2015 Dec 23.'}, {'pmid': '26581683', 'type': 'DERIVED', 'citation': 'Dostal AM, Samavat H, Espejo L, Arikawa AY, Stendell-Hollis NR, Kurzer MS. Green Tea Extract and Catechol-O-Methyltransferase Genotype Modify Fasting Serum Insulin and Plasma Adiponectin Concentrations in a Randomized Controlled Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Jan;146(1):38-45. doi: 10.3945/jn.115.222414. Epub 2015 Nov 18.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26206423', 'label': 'The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26051348', 'label': 'The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.\n\nPURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.\n\nThe investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.', 'detailedDescription': 'OBJECTIVES:\n\n1. Primary:\n\n 1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:\n 1. Mammographic density\n 2. Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)\n 3. Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG)\n\n 1.2 To determine the effects of COMT genotype on the green tea extract effects described above.\n2. Secondary:\n\n2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:\n\n1. Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)\n2. Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress\n\n2.2 To determine the effects of COMT genotype on the green tea extract effects described above.\n\n2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Healthy postmenopausal women aged 50-70 years\n* "Heterogeneously dense" (51-75% glandular) or "extremely dense" (\\>75%glandular) breasts\n* Willing to avoid consumption of green tea for 1 year\n\nExclusion Criteria:\n\n* Positive serological markers of hepatitis B or hepatitis C infections\n* Elevated levels of liver enzymes\n* Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors\n* Current smoker of cigarettes or other tobacco products\n* BMI \\<19 or \\>40 kg/m2\n* Weight change \\> 10 lbs during the previous year\n* History of breast cancer or proliferative breast disease\n* Regular consumption of \\> 7 alcoholic drinks/wk\n* Regular consumption of green tea (\\>1 cup/wk)\n* Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors\n* Participation in any weight loss or weight gain studies\n* Currently taking Methotrexate or Enbrel\n* History of ovarian cancer\n* Any form of cancer in the last 5 years\n* Presence of implants'}, 'identificationModule': {'nctId': 'NCT00917735', 'briefTitle': 'Green Tea and Reduction of Breast Cancer Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes', 'orgStudyIdInfo': {'id': '0806M36121'}, 'secondaryIdInfos': [{'id': 'R01CA127236', 'link': 'https://reporter.nih.gov/quickSearch/R01CA127236', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Green tea extract', 'description': 'Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)', 'interventionNames': ['Drug: Green tea extract supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Green tea extract supplement', 'type': 'DRUG', 'otherNames': ['Green tea extract: Corban green tea blend (GTB-3D)'], 'description': 'Two green tea extract capsules twice daily after breakfast and dinner for one year', 'armGroupLabels': ['Green tea extract']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Sugar Pill'], 'description': 'Two placebo capsules twice daily after breakfast and dinner for one year', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Breast Center', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55369', 'city': 'Maple Grove', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Maple Grove Breast Center', 'geoPoint': {'lat': 45.07246, 'lon': -93.45579}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center (UMMC) Breast Clinic', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Institute', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55108', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Food Science and Nutrition, University of Minnesota', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Mindy S Kurzer, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}