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

History of Changes

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:

Drug Information available for: Garlic oil Allium sativum extract

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Protective Agents Physiological Effects of Drugs	Anticarcinogenic Agents Antineoplastic Agents Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016

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