The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II (OMEGA-PAD II)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01979874 |
Recruitment Status :
Completed
First Posted : November 8, 2013
Last Update Posted : July 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Arterial Disease | Dietary Supplement: Pro-Omega Other: ProOmega Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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)
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Dietary Supplement: Pro-Omega
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months |
Placebo Comparator: Placebo
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
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Other: ProOmega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months |
- Systemic Inflammatory bio-markers [ Time Frame: 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.
- Endothelial Function [ Time Frame: 3 months ]Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV).
- Walking Performance [ Time Frame: 3 months ]Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ).

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Ages Eligible for Study: | 50 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Intermittent claudication (Rutherford 1-3)
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One of the following:
- Resting or exercise ankle-brachial index (ABI) <0.9
- toe pressure < 70 mm Hg
- documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
- Age 50 and more
Exclusion Criteria:
- Critical limb ischemia
- Hypersensitivity/allergies to fish or seafood
- Already on n-3 PUFA or equivalent
- Significant renal, hepatic, and inflammatory disease
- Concurrent severe infections
- Acute illness (myocardial infarction, stroke, major surgery within 30 days)
- Receiving immunosuppressive medications or steroids
- Age < 50

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979874
United States, California | |
San Francisco Veterans Affairs Medical Center | |
San Francisco, California, United States, 94121 |
Principal Investigator: | Warren Gasper, MD | UCSF & SFVAMC |
Publications:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01979874 |
Other Study ID Numbers: |
13-11778 |
First Posted: | November 8, 2013 Key Record Dates |
Last Update Posted: | July 22, 2019 |
Last Verified: | July 2019 |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |