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Inflammation and Brain Function - Pilot Study

Inflammation Och hjärnfunktion - Pilotstudie

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03551080
Enrollment
8
Registered
2018-06-11
Start date
2009-10-31
Completion date
2009-12-31
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickness Behavior

Keywords

Sickness behavior, Cytokines, Psychoneuroimmunology

Brief 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

Interventions

Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)

BIOLOGICALPlacebo

Saline administered intravenously

Sponsors

University of California, San Francisco
CollaboratorOTHER
The Swedish Society of Medicine
CollaboratorOTHER
Swedish Heart Lung Foundation
CollaboratorOTHER
The Swedish Research Council
CollaboratorOTHER_GOV
Swedish Council for Working Life and Social Research
CollaboratorOTHER
Stockholm University
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects

Exclusion criteria

* Diagnosed physiological or psychiatric disease * Needle anxiety or blood phobia * Regular medication (excluding contraceptive pill) * Infection in the last two weeks * Pregnancy or breastfeeding * Smoking * Excessive alcohol use * Body mass index in the range of obesity (\>30 kg/m2) or underweight (\<18.5 kg/m2) * Invisible veins in the antecubital area of the arms

Design outcomes

Primary

MeasureTime frameDescription
Change in interoceptive vs exteroceptive focus7 hoursRating of concordance of heartbeat vs signal and change in tone of signal

Secondary

MeasureTime frameDescription
Change in facial apparence2 hoursPhotos were taken under standardised conditions before and after injection
Change in gait2 hThe participants were filmed walking before and after injection
Change in self-rated health7 hoursTwo questions were used to assess self-rated health 1how do you rate your general health status rated on a 5 grade Likert scale very good to very poor and 2how is your health right now rated on a 7 grade Likert scale from excellent to very poor
Change in pain perception7 hoursBoth deep and cutaneous pain at threshold and suprathreshold noxious levels. Heat- and cold (cutaneous) pain sensitivity was assessed for threshold stimuli and intense noxious stimuli, as well as pressure (deep) pain thresholds and CPM (descending pain inhibition).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026