Bioactive Lipids & PBMC

Investigations on the Role of Bioactive Lipids in the Control of PBMC Activation and Differentiation.

The investigators aim at harvesting PBMC from healthy donors to study the effect of the lipids mediators of interest. After isolation from the blood, PBMC will be activated as largely reported in the literature in the presence or absence of the tested lipids. The effect will be assessed by quantifying the expression of inflammatory markers. The expression of the receptors and enzymes potentially regulating the effects of the studied lipids will also be assessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Procedure: healthy volunteers blood sampling

Detailed Description

Data from the scientific literature support the hypothesis that bioactive lipids play an important role in inflammatory disorders. The levels of these bioactive lipids are altered in several pathophysiological conditions with an inflammatory component. The investigators and others have demonstrated that bioactive lipids affect the inflammatory tone in vivo in murine models as well as in in vitro models. However, confirming the translational value of these data is not easy in clinical studies. PBMC-based experiments are a powerful tool for us to validate our previous observations and will offer translational added value supporting further clinical investigations.

Thus, here the investigators aim at harvesting PBMC from healthy donors and use them to study the effect of the lipid mediators of interest (i.e. those showing interesting properties in our preclinical models). Blood will be collected from healthy volunteers, and PMBC isolated based on their density. After isolation from the blood, PBMC will be activated as largely reported in the literature (e.g. using phytohemagglutinin or lipopolysaccharides) in the presence or absence of the tested lipids. The effect will be assessed by quantifying the expression of inflammatory markers (by RT-qPCR and/or ELISA). The expression of the receptors and enzymes potentially regulating the effects of the studied lipids will be also assessed (by RT-qPCR).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulio Muccioli, prof; Email: giulio.muccioli@uclouvain.be
• Study Contact Backup: Name: Mireille Al Houayek, PhD; Email: mireille.alhouayek@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Volunteers must be able to give informed consent to be included in the study.
• no chronic inflammatory disease
• no acute inflammation

Exclusion Criteria:

• Men and women aged less than 18 years
• Pregnant women
• Prior diagnosis of a chronic inflammatory disease (for instance IBD, COPD, lupus, MS, etc. This is not an exhaustive list).
• Recent (<21 days) episode of acute inflammation or immune-altering event (e.g. cold, flu, vaccine, …).
• Chronic or recent use of drugs interfering with the immune / inflammatory response. Examples include (and are not limited to) NSAIDs, corticosteroids, aspirin, mABs, etc.
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy volunteers; One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them	Procedure: healthy volunteers blood sampling; One blood sample will be taken from healthy volunteers in order to isolate PBMC and to assess the effect of the lipid of interest on them PBMC will be activated in vitro (e.g. using LPS or PHA) in the presence or absence of the lipid of interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PBMC proliferation, differentiation or activation	Expression of inflammatory markers (e.g. cytokines: IL-1, IL-6,...), by RT-qPCR and/or ELISA	Throughout the study, an average of 5,5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the expression of enzymes or receptors and the PBMC activation state	Expression of the receptors known to mediate the effects of the lipids studied	Throughout the study, an average of 5,5 years

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Study Director: Giulio Muccioli, prof, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: inflammation
• Other Study ID Numbers: LIP-PBMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No