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

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ClinicalTrials.gov Identifier: NCT02719665
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Conte, MD, 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."

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Claudication Claudication, Intermittent Vascular Occlusion Vascular Calcification Vascular Diseases Osteoarthritis Dietary Supplement: SPM Emulsion, Dose-modality Dietary Supplement: SPM Softgel, Dose-Modality Dietary Supplement: Placebo Softgel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1a (OMEGA-SPM-DOSE)
PAD patients and healthy volunteers in study for SPM Emulsion, dose-modality.
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

Other Names:
  • Omega SPM
  • Specialized Pro-resolving Lipid Mediator Emulsion

Active Comparator: SPM - Phase 1b (OMEGA-SPM-DOSE)
PAD and Osteoarthritis (OA) patients using softgel, dose-modality.
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
Other Name: Omega SPM Bridging

Placebo Comparator: Placebo - Phase 1b (OMEGA-SPM-PLACEBO)
PAD and Osteoarthritis (OA) patients using softgel, dose-modality.
Dietary Supplement: Placebo Softgel
Days 43-47: 4 Placebo softgel; Day 48-64 Washout
Other Name: Omega SPM Bridging




Primary Outcome Measures :
  1. Optimal Phase 1b Dose [ Time Frame: 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.

  2. Change in the Resolution Index [ Time Frame: Baseline, Day 5 ]
    Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719665


Contacts
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Contact: Manveer Hundal, B.A 4153534379 Manveer.Hundal@ucsf.edu
Contact: Michael Henne, MPH 4155146064 Michael.Henne@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Manveer Hundal    415-353-4379    manveer.hundal@ucsf.edu   
Contact: Crystal Lala    415-353-4374    crystal.lala@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michael Conte, M.D. University of California, San Francisco

Publications:

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Responsible Party: Michael Conte, MD, Chief of Vascular and Endovascular Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02719665     History of Changes
Other Study ID Numbers: 15-17371
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Conte, MD, University of California, San Francisco:
peripheral arterial disease
claudication
PAD
Vascular Disease
Vascular Occlusion
Vacular Calcification
intermittent claudication
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Calcinosis
Vascular Calcification
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms
Calcium Metabolism Disorders
Metabolic Diseases