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SuspendedNCT00275405Updated Mar 20, 2007

Effect of Garlic on Inflammatory Mediators

A Phase 4 interventional study of Garlic Oil Macerate in Healthy, sponsored by Albany Medical College. Suspended at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-03-20.

Sponsored by Albany Medical College · Phase 4, Interventional, and Treatment

Why this study was suspended
Results inconclusive
Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Effects of Garlic
03

In context

Lead sponsor

Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants

Interventions

  • DrugGarlic Oil Macerate
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

1 site
  • Albany Medical Center
    Albany, New York 12208, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00275405
Lead sponsor
Albany Medical College
First posted
Jan 12, 2006
Start date
Apr 2006
Completion
Mar 2007 (estimated)
Last update
Mar 20, 2007

Study contacts

Howard S Smith, MD
principal investigator · Albany Medical College
Shaker A Mousa, PhD
principal investigator · Albany College of Pharmacy
Ahmad Aljada, PhD
principal investigator · Albany College of Pharmacy
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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