Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-04-05 @ 5:44 PM
Study NCT ID:
NCT02600650
Status:
UNKNOWN
Last Update Posted:
2015-11-09
First Post:
2015-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndogenousTestosterone Response to a Testosterone Boosting Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in concentration of salivary free testosterone from baseline measured by ELISA', 'timeFrame': '4 weeks', 'description': 'Change in concentration of salivary free testosterone from baseline to 4 weeks will be measured by ELISA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Testosterone']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether a proprietary 'testosterone-boosting' supplement, when used as recommended by the manufacturer, results in an increase in testosterone levels as measured by a salivary free testosterone assay.", 'detailedDescription': 'The experimental intervention in this study is the daily administration of a testosterone boosting supplement or sham supplement for 4 weeks. The supplement will be administered daily in capsule form. The control group will be given a sham capsule containing the carrier components of the supplement. Participants will be asked not to modify their current lifestyle. Salivary testosterone levels will be assessed prior to the intervention to collect a baseline measurement for each subject, and following the intervention to evaluate any changes in hormone levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male aged 20 to 40 years.\n* Fluent in English.\n\nExclusion Criteria:\n\n* Currently receiving hormonal therapy or testosterone boosting supplement.\n* Has received hormonal therapy or testosterone boosting supplement within 3 months prior to study.\n* Has experienced adverse event following previous exposure to testosterone boosting supplements.'}, 'identificationModule': {'nctId': 'NCT02600650', 'briefTitle': 'EndogenousTestosterone Response to a Testosterone Boosting Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Memorial Chiropractic College'}, 'officialTitle': 'EndogenousTestosterone Response to a Testosterone Boosting Supplement', 'orgStudyIdInfo': {'id': '151004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Receive daily authentic Testosterone boosting supplement', 'interventionNames': ['Dietary Supplement: Testosterone boosting supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Receive daily placebo supplementation', 'interventionNames': ['Dietary Supplement: Placebo Comparator']}], 'interventions': [{'name': 'Testosterone boosting supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Proprietary formulation of Testosterone boosting supplement administered daily', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo Comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily administration of Placebo Comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2H 3J1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'mark fillery, B.A.', 'role': 'CONTACT', 'email': 'mfillery@cmcc.ca', 'phone': '+1 416 482-2340', 'phoneExt': '267'}, {'name': 'brian budgell, Ph.D.', 'role': 'CONTACT', 'email': 'bbudgell@cmcc.ca', 'phone': '+1 416 482-2340', 'phoneExt': '151'}, {'name': 'brian budgell, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canadian Memorial Chiropractic College', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'mark fillery, B.A.', 'role': 'CONTACT', 'email': 'mfillery@cmcc.ca', 'phone': '+1 416 482-2340', 'phoneExt': '267'}, {'name': 'brian budgell, Ph.D.', 'role': 'CONTACT', 'email': 'bbudgell@cmcc.ca', 'phone': '+1 416 482-2340', 'phoneExt': '151'}], 'overallOfficials': [{'name': 'brian budgell, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canadian Memorial Chiropractic College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Memorial Chiropractic College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iovate Health Sciences International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Brian Budgell', 'investigatorAffiliation': 'Canadian Memorial Chiropractic College'}}}}