The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Endothelial Function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
Intervention: Pro-Omega (Dietary Supplement)
Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
Intervention: Omega 3 Fatty Acid (Dietary Supplement)
Placebo
Intervention: Pro-Omega (Dietary Supplement)
Placebo
Intervention: Omega 3 Fatty Acid (Dietary Supplement)
Outcomes
Primary Outcomes
Endothelial Function
Time Frame: 1 month
Flow-mediated, brachial artery vasodilation (FMD)
Secondary Outcomes
- Inflammatory bio-markers(1 month)