Effects of inflammation on stress responses in healthy men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to investigate how inflammation affects stress responses in the brains of healthy men. Participants will receive an injection of lipopolysaccharide (LPS), which induces inflammation, and then undergo brain imaging using fMRI and PET scans while performing a psychological stress task. The study employs a randomized, triple-blind, placebo-controlled, cross-over design, ensuring that each participant experiences both the LPS and placebo conditions with a wash-out period in between. The goal is to better understand the relationship between neuroinflammation and stress sensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male
* Healthy
* Age 18-45 years
* BMI 18.5-25 kg/m2
* Proficient in English and/or Dutch

Exclusion Criteria:

* Have previous or current neuropsychiatric disorders or have history of major head trauma
* Have any disorder, which in the Investigator's opinion might jeopardise your safety or compliance with the study
* Have any prior or current treatment(s) that might jeopardise your safety or that would compromise the integrity of the study
* Have any prior and recent medication use (especially antibiotics, cardiovascular drugs, steroids, non-steroid anti-inflammatory drugs, centrally effective drugs)
* Are participating in an interventional Trial with an investigational medicinal product (IMP) or device
* Have current or previous infection or vaccination within the last 8 weeks
* Have pathological values of blood indices and certain genetic profiles that will affect brain imaging results (we will conduct a blood screening before starting the study)
* Had strong physical activity (e.g. swimming, football, running more than 8 km per hour, carrying heavy loads) 24h before the start of the experiment.
* Are a smoker
* Are a night-shift worker
* Have recent or previous use of psychotropics within the last year
* Have regular high alcohol use (\>4 drinks/week)
* Have any brain imaging contraindications:

  * Have claustrophobia or too much uneasiness in limited spaces (in order to tolerate confinement during the scanning procedures).
  * Have severe back problems that will interfere with lying on your back in the scanner with no movement for long durations.
  * Have any condition that would interfere with MRI studies (e.g., cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, and metallic body inclusion or other metal implanted in the body). To check this, you will need to fill out a checklist before the procedure.
* You and/or your partner is planning to become pregnant during and up to one month of the completion of the study

Where it's running

• UZ/KU Leuven
  Leuven, Flemish Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Lukas Van Oudenhove, MD, PhD — KU Leuven
• Study coordinator: Lukas Van Oudenhove, MD, PhD
• Email: lukas.vanoudenhove@kuleuven.be
• Phone: +3216330147

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.