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NCT Number: NCT05161702

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SCF Pharma

Rimouski, Quebec, G0K 1P0, Canada

Location status: Recruiting

Location contact

Samuel Fortin, PhD

CONTACT

[email protected]

418-750-8590

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant aged of at least 18 years old.

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.

Treatment and study plan

MAG-SPM treatment on isolated PBMC cells

Other

Cells are isolated form the participant's blood donation (4x 10mL k2EDTA tubes per participant) and maintained in culture with LPS, a pro-inflammatory and pro-proliferative agent. Then, PBMC are separated in two, one half treated with MAG-SPM and the other half remains with LPS only. Proliferative activities are measured and compared in both cell dish.

Isolated PBMC cells without treatment.

Other

Cells are isolated form the participant's blood donation (4x 10mL k2EDTA tubes per participant) and maintained in culture with LPS, a pro-inflammatory and pro-proliferative agent. Then, PBMC are separated in two, one half treated with MAG-SPM and the other half remains with LPS only. Proliferative activities are measured and compared in both cell dish.

Primary outcomes

  1. Number of PBMC cells count

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Julie Landry, M.Sc

CONTACT

[email protected]

Samuel Fortin, PhD

CONTACT

[email protected]

418-750-8590

Sponsors and collaborators

Lead sponsor

SCF Pharma

Industry

Registry information

Acronym: PBMC

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.