Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Sponsor
- Albany Medical College
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- 1. To examine the pharmacokinetics of the garlic oil macerate.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Outcomes
Primary Outcomes
1. To examine the pharmacokinetics of the garlic oil macerate.
Secondary Outcomes
- 2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.