Effect of Garlic on Inflammatory Mediators

March 19, 2007 updated by: Albany Medical College

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1. To examine the pharmacokinetics of the garlic oil macerate.

Secondary Outcome Measures

Outcome Measure
2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Anticipated)

March 1, 2007

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2007

Last Update Submitted That Met QC Criteria

March 19, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ajoene

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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