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

NCT ID: NCT06620679

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

LPS then Saline

A crossover arm where the participant first receives the intervention (LPS), undergoes a wash-out period, then receives the placebo (saline).

Group Type: EXPERIMENTAL

Lipopolysaccharide (LPS)

Intervention Type: BIOLOGICAL

Lipopolysaccharide (LPS), single i.v. bolus, 0.4 ng/kg body weight

Placebo

Intervention Type: OTHER

Normal saline, single i.v. bolus, in equal volume to intervention

Saline then LPS

A crossover arm where the participant first receives the placebo (saline), undergoes a wash-out period, then receives the intervention (LPS).

Group Type: EXPERIMENTAL

Lipopolysaccharide (LPS)

Intervention Type: BIOLOGICAL

Lipopolysaccharide (LPS), single i.v. bolus, 0.4 ng/kg body weight

Placebo

Intervention Type: OTHER

Normal saline, single i.v. bolus, in equal volume to intervention

Interventions

Lipopolysaccharide (LPS)

Lipopolysaccharide (LPS), single i.v. bolus, 0.4 ng/kg body weight

Intervention Type: BIOLOGICAL

Placebo

Normal saline, single i.v. bolus, in equal volume to intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Lukas Van Oudenhove

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Van Oudenhove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Kristin Verbeke, Pharm, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Boushra Dalile, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UZ/KU Leuven

Leuven, Flemish Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Lukas Van Oudenhove, MD, PhD

Role: CONTACT

lukas.vanoudenhove@kuleuven.be

+3216330147

Dina Satriawan, MD, Mnsci

Role: CONTACT

dina.satriawan@kuleuven.be

+3216710366

Facility Contacts

Lukas Van Oudenhove, MD, PhD

Role: primary

lukas.vanoudenhove@kuleuven.be

+3216330147

Dina Satriawan, MD, Mnsci

Role: backup

dina.satriawan@kuleuven.be

+3216710366

Lukas Van Oudenhove, MD, PhD

Role: backup

Kristin Verbeke, Pharm, PhD

Role: backup

Boushra Dalile, PhD

Role: backup

Other Identifiers

101002525

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S67872

Identifier Type: -

Identifier Source: org_study_id