Clinical trial NCT06018259: Bioactive Lipids & PBMC
Official title: Investigations on the Role of Bioactive Lipids in the Control of PBMC Activation and Differentiation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: inflammation
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in PBMC proliferation, differentiation or activation
timeFrame: Throughout the study, an average of 5,5 years
Secondary outcomes:
measure: Correlation between the expression of enzymes or receptors and the PBMC activation state
timeFrame: Throughout the study, an average of 5,5 years
Other outcomes:
Locations:
Study officials:
affiliation: Université Catholique de Louvain
name: Giulio Muccioli, prof
role: STUDY_DIRECTOR
References: