Effects of inflammation on stress responses in healthy men
Mapping the Effect of (neuro)inflammation on Stress Sensitivity in the Brain of Healthy Men
This study is testing how inflammation affects stress responses in healthy men by giving them an injection that causes inflammation and then observing their brain activity during stress tasks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Flemish Brabant) |
| Trial ID | NCT06620679 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men aged 18-45 with a BMI between 18.5 and 25.
Not a fit: Patients with neuropsychiatric disorders, major head trauma, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how inflammation influences stress responses, potentially leading to new therapeutic strategies for stress-related disorders.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have explored the effects of inflammation on stress responses, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Flemish Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.