Bioactive Lipids & PBMC

Sponsor

Université Catholique de Louvain (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06018259

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: healthy volunteers blood sampling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

May 1, 2030

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation between the expression of enzymes or receptors and the PBMC activation state [Throughout the study, an average of 5,5 years]
Expression of the receptors known to mediate the effects of the lipids studied

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Université Catholique de Louvain

Investigators

Study Director: Giulio Muccioli, prof, Université Catholique de Louvain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT06018259

Other Study ID Numbers:

LIP-PBMC

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Université Catholique de Louvain

inflammation

Study Results

No Results Posted as of Aug 30, 2023