The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Systemic Inflammatory bio-markers
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Intermittent claudication (Rutherford 1-3)
- •One of the following:
- •Resting or exercise ankle-brachial index (ABI) <0.9
- •toe pressure < 70 mm Hg
- •documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
- •Age 50 and more
Exclusion Criteria
- •Critical limb ischemia
- •Hypersensitivity/allergies to fish or seafood
- •Already on n-3 PUFA or equivalent
- •Significant renal, hepatic, and inflammatory disease
- •Concurrent severe infections
- •Acute illness (myocardial infarction, stroke, major surgery within 30 days)
- •Receiving immunosuppressive medications or steroids
Arms & Interventions
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)
Intervention: Pro-Omega (Dietary Supplement)
Placebo
Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
Intervention: ProOmega Placebo (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Endothelial Function(3 months)