The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Dietary Supplement: Pro-Omega; Dietary Supplement: Omega 3 Fatty Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01310270

10-04615

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups, including a placebo group

Pro-Omega

Experimental group

Description:

High-dose, short-duration dietary omega-3 fatty acids supplementation

Treatment:

Dietary Supplement: Omega 3 Fatty Acid

Dietary Supplement: Pro-Omega

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Omega 3 Fatty Acid

Dietary Supplement: Pro-Omega