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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Dietary supplement: Pro-Omega; Dietary supplement: Omega 3 Fatty Acid

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	Flow-mediated, brachial artery vasodilation (FMD)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory bio-markers	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	1 month

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Warren Gasper, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2011
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 2, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (ESTIMATE): March 8, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Inflammation; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 10-04615