Effect of Garlic on Inflammatory Mediators

This study has suspended participant recruitment.
(Results inconclusive)
Sponsor:
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT00275405
First received: January 10, 2006
Last updated: March 19, 2007
Last verified: March 2007
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.

Resource links provided by NLM:


Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • 1. To examine the pharmacokinetics of the garlic oil macerate.

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

Estimated Enrollment: 34
Study Start Date: April 2006
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275405

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00275405     History of Changes
Other Study ID Numbers: Ajoene
Study First Received: January 10, 2006
Last Updated: March 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Albany Medical College:
Effects of Garlic

Additional relevant MeSH terms:
Allyl sulfide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014