Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 9:21 AM
Study NCT ID:
NCT01522703
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Whole Sprouts on Airway Allergic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ematsui@jhmi.edu', 'phone': '410-502-3858', 'title': 'Elizabeth Matsui, MD MHS', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Broccoli Sprouts', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alfalfa Sprouts (Placebo Control)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exhaled Nitric Oxide Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alfalfa Sprouts (Placebo Control)', 'description': 'ingestion of alfalfa sprouts for 3 consecutive days'}, {'id': 'OG001', 'title': 'Broccoli Sprouts', 'description': 'ingestion of broccoli sprouts for 3 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '32'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at 3 days', 'description': 'exhaled nitric oxide concentrations', 'unitOfMeasure': 'ppb', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Broccoli Sprouts', 'description': 'ingestion of broccoli sprouts 3 consecutive days'}, {'id': 'FG001', 'title': 'Alfalfa Sprouts (Placebo Control)', 'description': 'ingestion of alfalfa sprouts 3 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Broccoli Sprouts'}, {'id': 'BG001', 'title': 'Alfalfa Sprouts (Placebo Control)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-24', 'studyFirstSubmitDate': '2012-01-09', 'resultsFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-24', 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhaled Nitric Oxide Concentrations', 'timeFrame': 'at 3 days', 'description': 'exhaled nitric oxide concentrations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthma', 'allergic rhinitis', 'dietary interventions', 'mouse allergy'], 'conditions': ['Allergic Rhinitis', 'Asthma', 'Allergy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.\n\nThe study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* doctor diagnosis of asthma\n* aeroallergen sensitization\n* Non-smoker\n* Negative pregnancy test\n* Not breastfeeding\n* Normal TSH\n* For women, abstinent or using reliable birth control\n* Age 18-50 years\n* No other major pulmonary disease such as cystic fibrosis or COPD\n* Willingness to participate in study and sign consent form\n\nExclusion Criteria:\n\n* Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids\n* Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks\n* Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism\n* Pregnancy or nursing/breastfeeding mothers\n* On beta-blocker therapy\n* On reserpine, clonidine, imipramine, or related tricyclic drugs\n* Taking anti-oxidant supplements\n* Planned dietary changes during the study period\n* Unable to stop antihistamines prior to skin testing\n* Food allergy to Broccoli Sprouts or Alfalfa Sprouts\n* Omalizumab use within the last 12 months\n* Nasal polyps'}, 'identificationModule': {'nctId': 'NCT01522703', 'briefTitle': 'Effects of Whole Sprouts on Airway Allergic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation', 'orgStudyIdInfo': {'id': 'NA_00067371'}, 'secondaryIdInfos': [{'id': '1P01ES018176-01', 'link': 'https://reporter.nih.gov/quickSearch/1P01ES018176-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Broccoli Sprouts', 'description': 'Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days', 'interventionNames': ['Drug: Broccoli Sprouts']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Alfalfa Sprouts', 'description': 'Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Broccoli Sprouts', 'type': 'DRUG', 'otherNames': ['sprouts, broccoli sprouts'], 'description': '100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.', 'armGroupLabels': ['Broccoli Sprouts']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sprouts, alfalfa, broccoli sprouts'], 'description': 'Alfalfa Sprouts', 'armGroupLabels': ['Alfalfa Sprouts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Elizabeth Matsui, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elizabeth Matsui', 'investigatorAffiliation': 'Johns Hopkins University'}}}}