The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II

Phase 2

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Dietary Supplement: Pro-Omega; Other: ProOmega Placebo

• Registration Number: NCT01979874
• Lead Sponsor: University of California, San Francisco

Brief Summary

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.

Detailed Description

The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3 months. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. Blood draws, vascular function testing and 6-minute walking tests will be performed at baseline and after 3 months. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules.

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Study Start: 2014-02
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Intermittent claudication (Rutherford 1-3)

2. One of the following:

   1. Resting or exercise ankle-brachial index (ABI) <0.9
   2. toe pressure < 70 mm Hg
   3. documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries

3. Age 50 and more

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Exclusion Criteria

1. Critical limb ischemia
2. Hypersensitivity/allergies to fish or seafood
3. Already on n-3 PUFA or equivalent
4. Significant renal, hepatic, and inflammatory disease
5. Concurrent severe infections
6. Acute illness (myocardial infarction, stroke, major surgery within 30 days)
7. Receiving immunosuppressive medications or steroids
8. Age < 50

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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; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day x 3 months (Nordic Naturals, Watsonville, CA, USA)
Placebo	ProOmega Placebo	Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months

Primary Outcome Measures

Name	Time	Method
Systemic Inflammatory bio-markers	3 months	reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.

Secondary Outcome Measures

Name	Time	Method
Endothelial Function	3 months	Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV).

Trial Locations

Locations (1)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States