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

NCT02719665 | Completed

• 1 other identifier: 15-17371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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."

Conditions

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

Keywords

peripheral arterial disease; claudication; PAD; Vascular Disease; Vascular Occlusion; Vacular Calcification; intermittent claudication; Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Optimal Phase 1b Dose

  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.

  Baseline, Day 33

• Change in the Resolution Index

  Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.

  Baseline, Day 5

Study Arms (3)

Phase 1a (OMEGA-SPM-DOSE)

EXPERIMENTAL

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

Dietary Supplement: SPM Emulsion, Dose-modality

SPM - Phase 1b (OMEGA-SPM-DOSE)

ACTIVE COMPARATOR

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

Dietary Supplement: SPM Softgel, Dose-Modality

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

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Softgel

Interventions

SPM Emulsion, Dose-modality DIETARY_SUPPLEMENT

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

Also known as: Omega SPM, Specialized Pro-resolving Lipid Mediator Emulsion

Phase 1a (OMEGA-SPM-DOSE)

SPM Softgel, Dose-Modality DIETARY_SUPPLEMENT

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

Also known as: Omega SPM Bridging

SPM - Phase 1b (OMEGA-SPM-DOSE)

Placebo Softgel DIETARY_SUPPLEMENT

Days 43-47: 4 Placebo softgel; Day 48-64 Washout

Also known as: Omega SPM Bridging

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (37)

• Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.

  PMID: 26296857 BACKGROUND

• Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.

  PMID: 24052491 BACKGROUND

• Akagi D, Chen M, Toy R, Chatterjee A, Conte MS. Systemic delivery of proresolving lipid mediators resolvin D2 and maresin 1 attenuates intimal hyperplasia in mice. FASEB J. 2015 Jun;29(6):2504-13. doi: 10.1096/fj.14-265363. Epub 2015 Mar 16.

  PMID: 25777995 BACKGROUND

• Chatterjee A, Sharma A, Chen M, Toy R, Mottola G, Conte MS. The pro-resolving lipid mediator maresin 1 (MaR1) attenuates inflammatory signaling pathways in vascular smooth muscle and endothelial cells. PLoS One. 2014 Nov 19;9(11):e113480. doi: 10.1371/journal.pone.0113480. eCollection 2014.

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• Miyahara T, Runge S, Chatterjee A, Chen M, Mottola G, Fitzgerald JM, Serhan CN, Conte MS. D-series resolvin attenuates vascular smooth muscle cell activation and neointimal hyperplasia following vascular injury. FASEB J. 2013 Jun;27(6):2220-32. doi: 10.1096/fj.12-225615. Epub 2013 Feb 13.

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• Schaller MS, Chen M, Colas RA, Sorrentino TA, Lazar AA, Grenon SM, Dalli J, Conte MS. Treatment With a Marine Oil Supplement Alters Lipid Mediators and Leukocyte Phenotype in Healthy Patients and Those With Peripheral Artery Disease. J Am Heart Assoc. 2020 Aug 4;9(15):e016113. doi: 10.1161/JAHA.120.016113. Epub 2020 Jul 22.

  PMID: 32696697 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Vascular Calcification; Vascular Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Conte, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: March 1, 2016
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

US (1)