NCT02719665

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Peripheral Arterial Disease
• Claudication
• Claudication, Intermittent
• Vascular Occlusion
• Vascular Calcification
• Vascular Diseases
• Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SPM Emulsion, Dose-modality	Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule: Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml
DIETARY_SUPPLEMENT	SPM Softgel, Dose-Modality	Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration
DIETARY_SUPPLEMENT	Placebo Softgel	Days 43-47: 4 Placebo softgel; Day 48-64 Washout

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2016-03-25
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States