Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT02931006
Status:
UNKNOWN
Last Update Posted:
2016-10-12
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Bovine Milk Consumption on Hormonal Profile in Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sex hormone profile', 'timeFrame': '4 hours after consumption', 'description': 'gonadotropin levels (Testosterone, Estradiol)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gonadotrophin and Sex Hormone Changes']}, 'descriptionModule': {'briefSummary': '50 men will be recruited to this study. Participants will be asked to ingest commercially available bovine milk. Hormonal profile will be analyzed before and after consumption.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, non infertile males\n\nExclusion Criteria:\n\n* lactose intolerance'}, 'identificationModule': {'nctId': 'NCT02931006', 'briefTitle': 'Influence of Bovine Milk Consumption on Hormonal Profile in Males', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Influence of Bovine Milk Consumption on Hormonal Profile in Males', 'orgStudyIdInfo': {'id': 'Bovine Milk-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'interventionNames': ['Other: water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'experimental', 'interventionNames': ['Other: bovine milk']}], 'interventions': [{'name': 'water', 'type': 'OTHER', 'armGroupLabels': ['control']}, {'name': 'bovine milk', 'type': 'OTHER', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Ronit Kochman, MD', 'role': 'CONTACT', 'email': 'kochman.ronit@gmail.com', 'phone': '00 972 50 8946414'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Israel', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}