Clinical trial NCT02719665: THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
Official title: THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication
Claudication, Intermittent
Vascular Occlusion
Vascular Calcification
Vascular Diseases
Osteoarthritis
Keywords: peripheral arterial disease
claudication
PAD
Vascular Disease
Vascular Occlusion
Vacular Calcification
intermittent claudication
Osteoarthritis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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."

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Optimal Phase 1b Dose
timeFrame: Baseline, Day 33
measure: Change in the Resolution Index
timeFrame: Baseline, Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Michael Conte, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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