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

Study Purpose

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."

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02719665
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael Conte, M.D.
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Peripheral Arterial Disease, Claudication, Claudication, Intermittent, Vascular Occlusion, Vascular Calcification, Vascular Diseases, Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Phase 1a (OMEGA-SPM-DOSE)

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

Active Comparator: SPM - Phase 1b (OMEGA-SPM-DOSE)

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

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

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Site Contact

Manveer Hundal

[email protected]

415-353-4379

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