Effect of Garlic on Inflammatory Mediators | NCT00275405

Studies
Effect of Garlic on Inflammatory Mediators

NCT00275405

Sponsor

Albany Medical College

Status

Suspended

Last Update Posted

Mar 20, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Healthy

Interventions

Garlic Oil Macerate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Results inconclusive

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Estimated

First Submitted Date

Jan 10, 2006

First Submission Date that Met QC Criteria

Jan 10, 2006

First Posted Date

Jan 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2007

Last Update Posted Date

Mar 20, 2007Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Garlic Oil Macerate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. To examine the pharmacokinetics of the garlic oil macerate.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center		Albany	New York	12208	United States