Bioactive Lipids & PBMC

NCT06018259 | Not Yet Recruiting

• 1 other identifier: LIP-PBMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

inflammation

Outcome Measures

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

  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

  Throughout the study, an average of 5,5 years

Study Arms (1)

healthy volunteers

EXPERIMENTAL

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

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.

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giulio Muccioli, prof

  Université Catholique de Louvain

  STUDY DIRECTOR

Central Study Contacts

Giulio Muccioli, prof

CONTACT

giulio.muccioli@uclouvain.be

Mireille Al Houayek, PhD

CONTACT

mireille.alhouayek@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: August 30, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share