The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

University of California, San Francisco180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

180

Conditions

Peripheral Arterial Disease

Interventions

Pro-OmegaDIETARY_SUPPLEMENT

Pro-Omega, 4.4gm/day x 1 month

Omega 3 Fatty AcidDIETARY_SUPPLEMENT

4.4 gm/day for 1 month

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Endothelial Function

Flow-mediated, brachial artery vasodilation (FMD)

Time frame: 1 month

Secondary Outcomes

Inflammatory bio-markers

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

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.