Inflammation and Brain Function - Pilot Study

Sickness Behavior Clinical Trial

Official title:

Inflammation Och hjärnfunktion - Pilotstudie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551080
• Other study ID #: 2008/955-31
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?seq uence=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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Illness Behavior
• Inflammation
• Sickness Behavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in interoceptive vs exteroceptive focus	Rating of concordance of heartbeat vs signal and change in tone of signal	7 hours
Secondary	Change in self-rated health	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	7 hours
Secondary	Change in pain perception	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).	7 hours
Secondary	Change in facial apparence	Photos were taken under standardised conditions before and after injection	2 hours
Secondary	Change in gait	The participants were filmed walking before and after injection	2 h