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

NCT06620679 | Recruiting

• 2 other identifiers: S67872101002525
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Stress; Healthy Volunteer

Keywords

Inflammation; Stress; Lipopolysaccharide (LPS); Short-chain fatty acids; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• Blood-oxygenation-level-dependent functional magnetic resonance imaging (BOLD fMRI) response to acute stress task

  BOLD fMRI responses to the Montreal Imaging Stress Task (MIST) after administration of LPS compared to saline

  2 hours after the single i.v bolus administration of LPS or saline

• Binding potential of [18F]-DPA-714 radiotracer

  The change in \[18F\]-DPA-714 binding potential with and without LPS administration (%∆BPND)

  2 hours after the single i.v bolus administration of LPS or saline

Secondary Outcomes (15)

• Concentration of serum cytokines

  From 1 hour prior to intervention to 6 hours post-intervention

• Concentration of serum C-reactive protein (CRP)

  From 1 hour prior to intervention to 24 hours post-intervention

• Concentration of serum free cortisol

  From 1 hour prior to intervention to 24 hours post-intervention

• Concentration of plasma Adrenocorticotropic Hormone (ACTH)

  From 1 hour prior to intervention to 24 hours post-intervention

• Pulse rate

  From 1 hour prior to intervention to 6 hours post-intervention

Other Outcomes (3)

• Concentration of serum short-chain fatty acids (SCFAs)

  From 1 hour prior to intervention to 6 hours post-intervention

• Quantitative profile of microbiota

  On each intervention/placebo day

• Scoring of the Bristol Stool Score (BSS)

  On each intervention/placebo day

Study Arms (2)

LPS then Saline

EXPERIMENTAL

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

Biological: Lipopolysaccharide (LPS); Other: Placebo

Saline then LPS

EXPERIMENTAL

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

Biological: Lipopolysaccharide (LPS); Other: Placebo

Interventions

Lipopolysaccharide (LPS) BIOLOGICAL

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

LPS then Saline; Saline then LPS

Placebo OTHER

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

LPS then Saline; Saline then LPS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ/KU Leuven

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Lipopolysaccharides

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Biological Factors; Endotoxins; Bacterial Toxins; Toxins, Biological

Study Officials

• Lukas Van Oudenhove, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Kristin Verbeke, Pharm, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Boushra Dalile, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Van Oudenhove, MD, PhD

CONTACT

+3216330147; lukas.vanoudenhove@kuleuven.be

Dina Satriawan, MD, Mnsci

CONTACT

+3216710366; dina.satriawan@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available upon publication with no time limitations.
• Access Criteria: The data will be publicly available.

Locations

BE (1)