Inflammation and Brain Function - Pilot Study

Not Applicable

Completed

• Conditions: Sickness Behavior
• Interventions: Biological: Lipopolysaccharide; Biological: Placebo

• Registration Number: NCT03551080
• Lead Sponsor: Karolinska Institutet

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

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2018-05
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Healthy subjects

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Endotoxin	Lipopolysaccharide	0.8 ng lipopolysaccharide/kg body weight injection
Placebo	Placebo	Saline injection

Primary Outcome Measures

Name	Time	Method
Change in interoceptive vs exteroceptive focus	7 hours	Rating of concordance of heartbeat vs signal and change in tone of signal

Secondary Outcome Measures

Name	Time	Method
Change in facial apparence	2 hours	Photos were taken under standardised conditions before and after injection
Change in self-rated health	7 hours	Two questions were used to assess self-rated health 1"how do you rate your general health status" rated on a 5 grade Likert scale very good to very poor and 2"how is your health right now" rated on a 7 grade Likert scale from excellent to very poor
Change in pain perception	7 hours	Both 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).
Change in gait	2 h	The participants were filmed walking before and after injection