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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01310270

First received: March 2, 2011

Last updated: November 6, 2013

Last verified: November 2013

History of Changes

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: Double Blind (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


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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	March 2, 2011
Last Updated:	November 6, 2013

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 27, 2017

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