NCT06620679

Mapping the Effect of (neuro)inflammation on Stress Sensitivity in the Brain of Healthy Men

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to determine the effects of inflammation on stress responses in the brain of healthy men. In order to achieve this goal, participants are injected with an inflammation-inducing agent, then observed inside a brain scanner.

Detailed description

This interventional study is a randomized, triple-blind, placebo-controlled, cross-over study aiming to elucidate the impact of acute laboratory-induced inflammation using lipopolysaccharide (LPS) on stress responses in the brain of healthy men. Acute stress responses to a psychological task, the Maastricht Imaging Stress Task (MIST), are observed via blood-oxygenation-level-dependent functional magnetic resonance imaging (BOLD fMRI) and simultaneous positron emission tomography (PET) imaging using the radiotracer 18 Fluor (18F)-N,N-diethyl-2-\[4-(2-fluoroethoxy)phenyl\]-5,7-dimethylpyrazole\[1,5-a\]pyrimidine-3-acetamide (DPA)-714, which targets the 18 kilodalton (kDA) translocator protein (TSPO) of activated microglia. Every participant will receive 0.4 ng/kg body weight of LPS and saline on separate treatment visits, separated by a 2-3 months wash-out period.

Conditions

• Inflammation
• Stress
• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	Lipopolysaccharide (LPS)	Lipopolysaccharide (LPS), single i.v. bolus, 0.4 ng/kg body weight
OTHER	Placebo	Normal saline, single i.v. bolus, in equal volume to intervention

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Belgium