Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-20 @ 2:36 AM
Study NCT ID:
NCT00994604
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbrown2@jhmi.edu', 'phone': '410-614-5451', 'title': 'Dr. Robert Brown', 'organization': 'Johns Hokpins Medical Institutions'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'entire study', 'eventGroups': [{'id': 'EG000', 'title': 'Broccoli Sprout Extract', 'description': 'pre- and post-consumption of broccoli sprout extract for 2 weeks', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Broccoli Sprout Extract - BP', 'description': 'pre- and post-consumption of broccoli sprout extract for 2 weeks'}, {'id': 'OG001', 'title': 'Broccoli Sprout Extract - BD', 'description': 'pre- and post-consumption of broccoli sprout extract for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '57.1', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '30.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and two weeks', 'description': 'Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100\n\nBronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Airway Size by Computed Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Airway Size Pre BSE', 'description': 'CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).'}, {'id': 'OG001', 'title': 'Airway Size Post BSE', 'description': 'CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '32', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after two weeks', 'description': 'Changes in size airways as measured by computed tomography', 'unitOfMeasure': 'size in mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Broccoli Sprout Extract', 'description': 'pre- and post-consumption of broccoli sprout extract for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Broccoli Sprout Extract', 'description': 'broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-05', 'studyFirstSubmitDate': '2009-10-13', 'resultsFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-05', 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract', 'timeFrame': 'baseline and two weeks', 'description': 'Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100\n\nBronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100'}], 'secondaryOutcomes': [{'measure': 'Changes in Airway Size by Computed Tomography', 'timeFrame': 'baseline and after two weeks', 'description': 'Changes in size airways as measured by computed tomography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma', 'COPD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.', 'detailedDescription': 'Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.\n\nAlthough steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.\n\nOne compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.\n\nWe plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma\n* COPD\n\nExclusion Criteria:\n\n* currently on chronic oral steroid medications\n* current respiratory symptoms\n* pregnant\n* FEV1 less than 40% predicted at baseline\n* extreme degrees of bronchial hyperreactivity\n* recent respiratory infection (\\<3 weeks)\n* unstable symptoms in the prior month\n* a history of intubation for respiratory symptoms within the past year\n* any history of cardiac disease.'}, 'identificationModule': {'nctId': 'NCT00994604', 'briefTitle': 'The Effects of Broccoli Sprout Extract on Obstructive Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The Effects of Broccoli Sprout Extract on Obstructive Lung Disease', 'orgStudyIdInfo': {'id': 'RB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'broccoli sprout extract', 'description': 'This a before and after treatment study. The subjects will consumer broccoli sprout extract (BSE) for two weeks (14d). Lung function and Chest CT will be performed before and after BSE consumption.', 'interventionNames': ['Drug: broccoli sprout extract']}], 'interventions': [{'name': 'broccoli sprout extract', 'type': 'DRUG', 'description': 'consumption of broccoli sprout extract for 2 weeks', 'armGroupLabels': ['broccoli sprout extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institutions', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This was a pilot study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Brown', 'investigatorAffiliation': 'Johns Hopkins University'}}}}