Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00275405
Status:
SUSPENDED
Last Update Posted:
2007-03-20
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Garlic on Inflammatory Mediators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 34}}, 'statusModule': {'whyStopped': 'Results inconclusive', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-03-19', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. To examine the pharmacokinetics of the garlic oil macerate.'}], 'secondaryOutcomes': [{'measure': '2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.'}]}, 'conditionsModule': {'keywords': ['Effects of Garlic'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.', 'detailedDescription': "To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Normal subjects with BMI \\<25, obese subjects with BMI \\>30\n* Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.\n\nExclusion Criteria:\n\n* Subjects on any antioxidant medication.\n* Patient on non-steroidal anti-inflammatory drug.\n* On any agent with antioxidant properties.\n* History of drug or alcohol abuse.\n* Any life threatening disease.\n* On any agent with significant antioxidant properties.\n* Taking garlic extracts in the diet regularly.'}, 'identificationModule': {'nctId': 'NCT00275405', 'briefTitle': 'Effect of Garlic on Inflammatory Mediators', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.', 'orgStudyIdInfo': {'id': 'Ajoene'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Garlic Oil Macerate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Howard S Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}, {'name': 'Shaker A Mousa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany College of Pharmacy'}, {'name': 'Ahmad Aljada, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany College of Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}}}}