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Effect of Garlic on Inflammatory Mediators

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ClinicalTrials.gov Identifier: NCT00275405
Recruitment Status : Suspended (Results inconclusive)
First Posted : January 12, 2006
Last Update Posted : March 20, 2007
Sponsor:
Information provided by:
Albany Medical College

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Garlic Oil Macerate Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
Study Start Date : April 2006
Estimated Study Completion Date : March 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 1. To examine the pharmacokinetics of the garlic oil macerate.

Secondary Outcome Measures :
  1. 2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275405


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Howard S Smith, MD Albany Medical College
Principal Investigator: Shaker A Mousa, PhD Albany College of Pharmacy
Principal Investigator: Ahmad Aljada, PhD Albany College of Pharmacy
More Information
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ClinicalTrials.gov Identifier: NCT00275405    
Other Study ID Numbers: Ajoene
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: March 20, 2007
Last Verified: March 2007
Keywords provided by Albany Medical College:
Effects of Garlic
Additional relevant MeSH terms:
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Allyl sulfide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
 Anticarcinogenic Agents
Antineoplastic Agents
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors