Effect of Garlic on Inflammatory Mediators

Healthy Clinical Trial

Official title:

Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00275405
• Other study ID #: Ajoene
• Status: Suspended
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: March 19, 2007
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 34
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Garlic Oil Macerate

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To examine the pharmacokinetics of the garlic oil macerate.
Secondary	2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.