NCT03551080

Inflammation and Brain Function - Pilot Study

Inflammation Och hjärnfunktion - Pilotstudie

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this randomized double blind cross-over study 8 healthy persons were injected with 0.8 ng/kg body weight lipopolysaccharide (LPS) /endotoxin and placebo at two different occasions. The aim was to investigate how pain sensitivity and health perception change in response to an acute immune activation.

Detailed description

Eight healthy participants were included in this randomized and balanced double blind cross-over study. They were injected two times, once with the active component and once with placebo. Participants were recruited by advertising and screened through questionnaires and a health examination by a physician. They were asked not to engage in strenuous physical activities, sleep regular hours and refrain from alcohol the day before the experiment. If the participants felt ill, e.g. coming down with a cold, they were instructed to call and were rescheduled for a later appointment. C-reactive protein (CRP) was assessed to exclude participants having an ongoing infection on the experimental day. Pregnancy was also an exclusion criteria and a pregnancy test was administered for all female participants on arrival. Several pain sensitivity measures were performed baseline and at peak inflammatory response 1-2 hours after injection. Subjects filled out questionnaires at baseline, 90 minutes and 4,5 hours after injection. The study and the procedures used in the study are described in detail here: https://openarchive.ki.se/xmlui/bitstream/handle/10616/44650/Thesis\_Bianka\_Karshikoff.pdf?sequence=8\&isAllowed=y The following papers have been published using data from this study: Olsson MJ, Lundstrom JN, Kimball BA, Gordon AR, Karshikoff B, Hosseini N, Sorjonen K, Olgart Hoglund C, Solares C, Soop A, Axelsson J \& Lekander M. The Scent of Disease: Human Body Odor Contains an Early Chemosensory Cue of Sickness. Psychol Sci. 2014 Jan 22. Sundelin T, Karshikoff B, Axelsson E, Hoglund CO, Lekander M, Axelsson J. Sick man walking: Perception of health status from body motion. Brain Behav Immun. 2015;48:53-6. Karshikoff B, Lekander M, Soop A, Lindstedt F, Ingvar M Kosek E, Olgart Höglund C, \& Axelsson J. Modality and sex differences in pain sensitivity during human endotoxemia. Brain, Behavior, and Immunity. 2015 May;46:35-43

Conditions

• Sickness Behavior

Interventions

Type	Name	Description
BIOLOGICAL	Lipopolysaccharide	Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)
BIOLOGICAL	Placebo	Saline administered intravenously

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2018-06-11
• Last updated: 2018-06-11