THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/27/2018 |
| Start Date: | March 2016 |
| End Date: | December 2019 |
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."
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."
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 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.
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 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.
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Michael Conte, MD
Phone: 415-353-4366
Click here to add this to my saved trials
