The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01310270

First Posted: March 8, 2011

Last Update Posted: November 7, 2013

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.

Information provided by (Responsible Party):

University of California, San Francisco

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease	Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Endothelial Function [ Time Frame: 1 month ]
Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures:

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


Enrollment:	80
Study Start Date:	April 2011
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pro-Omega High-dose, short-duration dietary omega-3 fatty acids supplementation	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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, California
University of California San Francisco
San Francisco, California, United States, 94115

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Marlene Grenon, MD	University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.

Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM. Relationship between kidney disease and endothelial function in peripheral artery disease. J Vasc Surg. 2014 Dec;60(6):1605-11. doi: 10.1016/j.jvs.2014.08.105. Epub 2014 Oct 16.

Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070.

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.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01310270 History of Changes
Other Study ID Numbers:	10-04615
First Submitted:	March 2, 2011
First Posted:	March 8, 2011
Last Update Posted:	November 7, 2013
Last Verified:	November 2013

Additional relevant MeSH terms:


Inflammation Peripheral Arterial Disease Peripheral Vascular Diseases Pathologic Processes Atherosclerosis	Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases

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