The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Not Applicable
Completed
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT01310270
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- intermittent claudication
- resting or exercise Ankle-Brachial Index (ABI) <0.9
- age 50 and more
Exclusion Criteria
- critical limb ischemia
- hypersensitivity/allergies to fish or seafood
- already on omega-3 fatty acids or equivalent
- significant renal, hepatic, and inflammatory disease
- concurrent severe infections
- acute illness (MI, stroke, major surgery within 30 days)
- receiving immunosuppressive medications or steroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Endothelial Function 1 month Flow-mediated, brachial artery vasodilation (FMD)
- Secondary Outcome Measures
Name Time Method Inflammatory bio-markers 1 month Inflammatory bio-markers: C-reactive protein (hsCRP), interleukin-6 (IL-6), soluble intracellular adhesion molecule-1 (sICAM-1) and the anti-inflammatory mediator 15-epimeric lipoxin
Trial Locations
- Locations (1)
University of California San Francisco
🇺🇸San Francisco, California, United States
University of California San Francisco🇺🇸San Francisco, California, United States