The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)
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ClinicalTrials.gov Identifier: NCT01310270 |
Recruitment Status :
Completed
First Posted : March 8, 2011
Last Update Posted : November 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 180 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 |
Actual Study Start Date : | April 2011 |
Actual Primary Completion Date : | December 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
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Dietary Supplement: Pro-Omega
Pro-Omega, 4.4gm/day x 1 month Dietary Supplement: Omega 3 Fatty Acid 4.4 gm/day for 1 month |
Placebo Comparator: Placebo |
Dietary Supplement: Pro-Omega
Pro-Omega, 4.4gm/day x 1 month Dietary Supplement: Omega 3 Fatty Acid 4.4 gm/day for 1 month |
- Endothelial Function [ Time Frame: 1 month ]Flow-mediated, brachial artery vasodilation (FMD)
- Inflammatory bio-markers [ Time Frame: 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

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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): NCT01310270
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Warren Gasper, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01310270 |
Other Study ID Numbers: |
10-04615 |
First Posted: | March 8, 2011 Key Record Dates |
Last Update Posted: | November 5, 2021 |
Last Verified: | October 2021 |
Peripheral Arterial Disease Peripheral Vascular Diseases Inflammation Pathologic Processes Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |