Effect of Garlic on Inflammatory Mediators

NCT ID: NCT00275405

Last Updated: 2007-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Garlic Oil Macerate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Principal Investigators

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Howard S Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Shaker A Mousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Albany College of Pharmacy

Ahmad Aljada, PhD

Role: PRINCIPAL_INVESTIGATOR

Albany College of Pharmacy

Locations

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Albany Medical Center

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Ajoene

Identifier Type: -

Identifier Source: org_study_id

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