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Effect of Garlic on Inflammatory Mediators

This study has suspended participant recruitment.
(Results inconclusive)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275405
First Posted: January 12, 2006
Last Update Posted: March 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Albany Medical College
January 10, 2006
January 12, 2006
March 20, 2007
April 2006
Not Provided
1. To examine the pharmacokinetics of the garlic oil macerate.
Same as current
Complete list of historical versions of study NCT00275405 on ClinicalTrials.gov Archive Site
2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.
Same as current
Not Provided
Not Provided
 
Effect of Garlic on Inflammatory Mediators
Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: Garlic Oil Macerate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
34
March 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00275405
Ajoene
Not Provided
Not Provided
Not Provided
Not Provided
Albany Medical College
Not Provided
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
Albany Medical College
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP