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The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II (OMEGA-PAD II)

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ClinicalTrials.gov Identifier: NCT01979874
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Pro-Omega Other: ProOmega Placebo Phase 2

Detailed Description:
The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3 months. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. Blood draws, vascular function testing and 6-minute walking tests will be performed at baseline and after 3 months. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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 II
Study Start Date : February 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day x 3 months (Nordic Naturals, Watsonville, CA, USA)
 Dietary Supplement: Pro-Omega
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months
Placebo Comparator: Placebo
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
 Other: ProOmega Placebo
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Systemic Inflammatory bio-markers [ Time Frame: 3 months ]
    reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.


Secondary Outcome Measures :
  1. Endothelial Function [ Time Frame: 3 months ]
    Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV).


Other Outcome Measures:
  1. Walking Performance [ Time Frame: 3 months ]
    Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Intermittent claudication (Rutherford 1-3)

  2. One of the following:

    1. Resting or exercise ankle-brachial index (ABI) <0.9
    2. toe pressure < 70 mm Hg
    3. documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
  3. Age 50 and more

Exclusion Criteria:

  1. Critical limb ischemia
  2. Hypersensitivity/allergies to fish or seafood
  3. Already on n-3 PUFA or equivalent
  4. Significant renal, hepatic, and inflammatory disease
  5. Concurrent severe infections
  6. Acute illness (myocardial infarction, stroke, major surgery within 30 days)
  7. Receiving immunosuppressive medications or steroids
  8. Age < 50
Contacts and Locations
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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): NCT01979874


Locations
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United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Warren Gasper, MD UCSF & SFVAMC
More Information
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Additional Information:

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01979874    
Other Study ID Numbers: 13-11778
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases