THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

University of California San Francisco (UCSF)

Status: Completed

Conditions: Claudication, Intermittent; Claudication; Osteoarthritis; Vascular Calcification; Vascular Occlusion; Vascular Diseases; Peripheral Arterial Disease

Treatments: Dietary Supplement: Placebo Softgel; Dietary Supplement: SPM Softgel, Dose-Modality; Dietary Supplement: SPM Emulsion, Dose-modality

Study type: Interventional

Funder types: Other

Identifiers

NCT02719665

15-17371

Details and patient eligibility

About

The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

Full description

The OMEGA-SPM-DOSE trial and the OMEGA-SPM-PAD trial are two parts of a pilot study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Emulsion) on the metabolo-lipidomic profile of healthy volunteers and patients with Peripheral Arterial Disease(PAD). Ten healthy volunteers and ten patients with PAD will participate in Part 1a, the "OMEGA-SPM-DOSE Study". A follow-up, placebo controlled, prospective study on the best dosing modality determined in Phase 1a will then take place in a PAD and OA population (n=12), Phase 1b - the "OMEGA-SPM-PAD Study". Specific measurements will include targeted metabolo-lipidomic profiling, established markers of inflammation, and functional monocyte and macrophage assays. The proposed studies have the potential to provide important new insights on the role of nutritional interventions in PAD.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy Volunteers:

-Age 20-80

PAD Patients:

• Mild claudication to rest pain (Rutherford 1-4)
• Resting or exercise ABI < 0.9 or TBI < 0.6
• Age 40 and more

OA Patients:

-Lower extremity (hip or knee) OA

Exclusion criteria

PAD, OA Patients and Healthy Volunteers:

• Plan to undergo surgical procedure or PVI for treatment of PAD within one month
• Evidence of active infection
• Hypersensitivity or allergy to fish or seafood
• Already on n-3 PUFA or equivalent
• Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disorders
• Poorly controlled diabetes (HbA1C > 8%)
• BMI < 20 or >35
• Recent other major surgery or illness within 30 days
• Use of immunosuppressive medications or steroids
• History of organ transplantation
• Pregnancy, or plans to become pregnant, or lactating

Healthy Volunteers:

• hsCRP > 2mg/L
• Regular aspirin use
• Regular non-steroidal anti-inflammatory drug use

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Phase 1a (OMEGA-SPM-DOSE)

Experimental group

Description:

PAD patients and healthy volunteers in study for SPM Emulsion, dose-modality.

Treatment:

Dietary Supplement: SPM Emulsion, Dose-modality

SPM - Phase 1b (OMEGA-SPM-DOSE)

Active Comparator group

Description:

PAD and Osteoarthritis (OA) patients using softgel, dose-modality.

Treatment:

Dietary Supplement: SPM Softgel, Dose-Modality

Placebo - Phase 1b (OMEGA-SPM-PLACEBO)

Placebo Comparator group

Description:

PAD and Osteoarthritis (OA) patients using softgel, dose-modality.

Treatment:

Dietary Supplement: Placebo Softgel