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NCT01979874 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— OMEGA-PAD II  

Official title:
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01979874
Other study ID # 13-11778
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2014
Est. completion date September 2017

Study information
Verified date July 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility 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

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

Study Design

Related Conditions & MeSH terms

Intervention

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
Other:
• ProOmega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months

Locations
Country Name City State
United States San Francisco Veterans Affairs Medical Center San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27. — View Citation

Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2. — View Citation

Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175. Review. — View Citation

Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Walking Performance Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ). 3 months
Primary Systemic Inflammatory bio-markers reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes. 3 months
Secondary Endothelial Function Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV). 3 months
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