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

Not Applicable

Completed

• Conditions: Claudication, Intermittent; Vascular Occlusion; Vascular Diseases; Osteoarthritis; Peripheral Arterial Disease; Claudication; Vascular Calcification
• Interventions: Dietary Supplement: SPM Emulsion, Dose-modality; Dietary Supplement: SPM Softgel, Dose-Modality; Dietary Supplement: Placebo Softgel

• Registration Number: NCT02719665
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1a (OMEGA-SPM-DOSE)	SPM Emulsion, Dose-modality	PAD patients and healthy volunteers in study for SPM Emulsion, dose-modality.
SPM - Phase 1b (OMEGA-SPM-DOSE)	SPM Softgel, Dose-Modality	PAD and Osteoarthritis (OA) patients using softgel, dose-modality.
Placebo - Phase 1b (OMEGA-SPM-PLACEBO)	Placebo Softgel	PAD and Osteoarthritis (OA) patients using softgel, dose-modality.

Primary Outcome Measures

Name	Time	Method
Change in the Resolution Index	Baseline, Day 5	Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.
Optimal Phase 1b Dose	Baseline, Day 33	The smallest dose administered in Phase 1a participants which results in an increase in Resolution Index at least 3 times that of baseline, or the subsequent larger dose resulting in a Resolution Index greater than 2 times that of the preceding does with no increase in side effects at the larger dose.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States