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NCT Number: NCT06018259

Bioactive Lipids & PBMC

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

healthy volunteers blood sampling

Procedure

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.

Primary outcomes

  1. Change in PBMC proliferation, differentiation or activation

    Time frame: 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 outcomes

  1. Correlation between the expression of enzymes or receptors and the PBMC activation state

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

    Expression of the receptors known to mediate the effects of the lipids studied

Study contacts

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

Giulio Muccioli, prof

CONTACT

[email protected]

Mireille Al Houayek, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

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.

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