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The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

NCT ID: NCT01310270

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pro-Omega

High-dose, short-duration dietary omega-3 fatty acids supplementation

Group Type EXPERIMENTAL

Pro-Omega

Intervention Type DIETARY_SUPPLEMENT

Pro-Omega, 4.4gm/day x 1 month

Omega 3 Fatty Acid

Intervention Type DIETARY_SUPPLEMENT

4.4 gm/day for 1 month

Placebo

Group Type PLACEBO_COMPARATOR

Pro-Omega

Intervention Type DIETARY_SUPPLEMENT

Pro-Omega, 4.4gm/day x 1 month

Omega 3 Fatty Acid

Intervention Type DIETARY_SUPPLEMENT

4.4 gm/day for 1 month

Interventions

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Pro-Omega

Pro-Omega, 4.4gm/day x 1 month

Intervention Type DIETARY_SUPPLEMENT

Omega 3 Fatty Acid

4.4 gm/day for 1 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warren Gasper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26296857 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25441679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25406739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24052491 (View on PubMed)

Other Identifiers

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10-04615

Identifier Type: -

Identifier Source: org_study_id