CClinicalTrials.gg
Not yet recruitingNCT06018259Updated Aug 30, 2023

Bioactive Lipids & PBMC

An interventional study of healthy volunteers blood sampling in Healthy, sponsored by Université Catholique de Louvain. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Healthy

Keywords

  • inflammation
03

In context

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurehealthy 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.

06

What researchers measure

Primary outcomes

  1. Change in PBMC proliferation, differentiation or activation

    Expression of inflammatory markers (e.g. cytokines: IL-1, IL-6,...), by RT-qPCR and/or ELISA

    Time frame: Throughout the study, an average of 5,5 years

Secondary outcomes

  1. 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

    Time frame: Throughout the study, an average of 5,5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06018259
Lead sponsor
Université Catholique de Louvain
Responsible party
Sponsor
First posted
Aug 30, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
May 2028 (estimated)
Completion
May 2030 (estimated)
Last update
Aug 30, 2023

Study contacts

Giulio Muccioli, prof
Contact
giulio.muccioli@uclouvain.be
Mireille Al Houayek, PhD
Contact
mireille.alhouayek@uclouvain.be
Giulio Muccioli, prof
study director · Université Catholique de Louvain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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