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

Conditions

Peripheral Arterial Disease

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.

S. Marlene Grenon, Christopher Owens, Emily Nosova, Millie Hughes‐Fulford, Hugh Alley et al. (12 authors)

Journal of the American Heart Association2015-08-2583 citations

10.1161/jaha.115.002034

Abstract 285: Rapid Change In Red Blood Cell PUFA Composition With High-dose Fish Oil Supplementation In Patients With Peripheral Artery Disease (PAD).

Marlene Grenon, Hugh Alley, Christine Hall, Sandra Pérez, Warren J. Gasper et al. (8 authors)

Arteriosclerosis Thrombosis and Vascular Biology2015-05-01

10.1161/atvb.35.suppl_1.285

Relationship between kidney disease and endothelial function in peripheral artery disease.

Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM.

2014-10-168 citations

10.1016/j.jvs.2014.08.105

Abstract 134: Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Downstream n-3 Fatty Acid Metabolites in Patients With Peripheral Artery Disease

Marlene Grenon, Christopher Owens, Hugh Alley, Karen Chong, Priscilla K. Yen et al. (8 authors)

Arteriosclerosis Thrombosis and Vascular Biology2014-05-01

10.1161/atvb.34.suppl_1.134

Interventions

DIETARY_SUPPLEMENTPro-Omega

Pro-Omega, 4.4gm/day x 1 month

DIETARY_SUPPLEMENTOmega 3 Fatty Acid

4.4 gm/day for 1 month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Endothelial Function	1 month	Flow-mediated, brachial artery vasodilation (FMD)

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed