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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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 1 Interventional N/A and older University of California, San Francisco 15-17371
NCT02719665
 Ongoing but not enrolling patients

Study Design:

Principal Investigator

Interim Chief, Division of Cardiothoracic Surgery
Professor & Chief, Division of Vascular and Endovascular Surgery
Edwin J. Wylie, M.D. Chair in Vascular Surgery
Co-Director, UCSF Heart and Vascular Center
Co-Director, UCSF Center for Limb Preservation
Director, Vascular Surgery Fellowship & Integrated Residency Programs

Clinical Research Coordinator

Trial 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."

Eligibility

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
Exclusion Criteria:
PAD 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

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 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 wider PAD population (n=30), 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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 11/17/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
 
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