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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Dietary Supplement: Pro-Omega; Dietary Supplement: Omega 3 Fatty Acid	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Sukaynah Khetani, BS	415-353-4368	sukaynah.khetani@ucsf.edu
Contact: David Cheng, MD	415-221-4810 ext 4708	david.cheng4@va.gov

Locations

United States, California
University of California San Francisco	Recruiting
San Francisco, California, United States, 94115
Contact: Sukaynah Khetani 415-221-4810 sukaynah.khetani@ucsf.edu
Principal Investigator: Marlene Grenon, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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:	Marlene Grenon, M.D, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01310270 History of Changes
Other Study ID Numbers:	10-04615
First Posted:	March 8, 2011
Last Update Posted:	January 4, 2018
Last Verified:	January 2018

Additional relevant MeSH terms:

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