Increased Inflammation-resolving Activity by Omega-3 Monoglycerides in Peripheral Blood Mononuclear Cells (PBMC).

Last updated: January 30, 2024
Sponsor: SCF Pharma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Treatment

MAG-SPM treatment on isolated PBMC cells

Isolated PBMC cells without treatment.

Clinical Study ID

NCT05161702
PBMC
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this biological study is to provide Dr. Samuel Fortin's laboratory with a continuous supply of blood mononuclear cells (PBMCs) so that he can pursue research on the potential beneficial effects of monoglyceride omega-3 fatty acids on the resolution of inflammation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant aged of at least 18 years old.

Exclusion

Exclusion Criteria:

  • Participant who use omega-3 supplements and / or anti-inflammatory medication such as,but not limited to - Aspirin, Ibuprofen (Motrin, Advil), Celecoxib (Celebrex),diclofenac (Cambia, Cataflam, Voltaren ) within 7 days of day 1 of the study.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: MAG-SPM treatment on isolated PBMC cells
Phase:
Study Start date:
March 12, 2019
Estimated Completion Date:
January 01, 2026

Study Description

The biological activity of omega-3 fatty acids requires selective oxidation by lipoxygenase (LOX) enzymes in the human body to form SPM (Specialized Pro-resolving Mediators). The formulations based on omega-3 monoglyceride (MAG-Omega-3) currently marketed by SCF Pharma have been optimized so as not to interfere with this natural metabolism process in the human body. It has already been shown that the antiproliferative activity of docosapentaenoic acid (or omega-3 ADP) can be increased tenfold when it is pre-metabolized using a LOX enzyme from soybean (C. Morin et al. PLEFA (2013) 203-213). This antiproliferative potential may play a key role in the mechanisms of inflammation resolution.

We now want to develop a new line of high performance products by pre-metabolizing MAG-Omega-3 in the form of SPM monoglycerides (MAG-SPM) using the LOX enzyme from soy. The potential for resolving inflammation by MAG-SPM can be measured by cell proliferation assays. To perform these tests, cells of the PBMC type must be isolated from the blood of donors and maintained in culture in the presence of an inflammatory agent (LPS) which induces their proliferation (C. Morin et al. European Journal of Pharmacology 807 (2017)) 205-211). Next, the reduction in proliferation induced by MAG-SPM is quantified and then compared with that of cells not treated with MAG-SPM. This type of test requires a large amount of fresh cells, and therefore, a source of blood sample supply.

This research project is divided into two parts: 1) A protocol for collecting blood samples; 2) A cell proliferation test protocol to demonstrate the activity of MAG-SPM in the resolution of inflammation. This protocol covers the first part of this research project.

Connect with a study center

  • SCF Pharma

    Rimouski, Quebec G0K 1P0
    Canada

    Active - Recruiting

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