This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.

Condition	Intervention	Phase
Healthy	Drug: Garlic Oil Macerate	Phase IV

Further study details as provided by Albany Medical College:

Primary Outcomes: 1. To examine the pharmacokinetics of the garlic oil macerate.
Secondary Outcomes: 2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.
Expected Total Enrollment:  34

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 moleculae-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasmingen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 18 years of age and older
• Normal subjects with BMI <25, obese subjects with BMI >30
• Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.

Exclusion Criteria:

• Subjects on any antioxidant medication.
• Patient on non-steroidal anti-inflammatory drug.
• On any agent with antioxidant properties.
• History of drug or alcohol abuse.
• Any life threatening disease.
• On any agent with significant antioxidant properties.
• Taking garlic extracts in the diet regularly.

Please refer to this study by ClinicalTrials.gov identifier  NCT00275405

Howard S Smith, MD      518-262-4461    smithH@mail.amc.edu
Ahmad Aljada, PhD      518-242-7883    aljadaa@acp.edu

New York
      Albany Medical Center, Albany,  New York,  12208,  United States

Study chairs or principal investigators

Howard S Smith, MD,  Principal Investigator,  Albany Medical College   
Shaker A Mousa, PhD,  Principal Investigator,  Albany College of Pharmacy   
Ahmad Aljada, PhD,  Principal Investigator,  Albany College of Pharmacy   

Study ID Numbers:  Ajoene
Last Updated:  January 11, 2006
Record first received:  January 10, 2006
ClinicalTrials.gov Identifier:  NCT00275405
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-17