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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Dietary Supplement: Pro-Omega; Dietary Supplement: Omega 3 Fatty Acid

• 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

Study Timeline

• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Study Start: 2011-04
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pro-Omega	Pro-Omega	High-dose, short-duration dietary omega-3 fatty acids supplementation
Pro-Omega	Omega 3 Fatty Acid	High-dose, short-duration dietary omega-3 fatty acids supplementation
Placebo	Pro-Omega	-
Placebo	Omega 3 Fatty Acid	-

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