Inflammation and Brain Function - Pilot Study
Primary Purpose
Sickness Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lipopolysaccharide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Sickness Behavior focused on measuring Sickness behavior, Cytokines, Psychoneuroimmunology
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Endotoxin
Placebo
Arm Description
0.8 ng lipopolysaccharide/kg body weight injection
Saline injection
Outcomes
Primary Outcome Measures
Change in interoceptive vs exteroceptive focus
Rating of concordance of heartbeat vs signal and change in tone of signal
Secondary Outcome Measures
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
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).
Change in facial apparence
Photos were taken under standardised conditions before and after injection
Change in gait
The participants were filmed walking before and after injection
Full Information
NCT ID
NCT03551080
First Posted
May 29, 2018
Last Updated
May 29, 2018
Sponsor
Karolinska Institutet
Collaborators
University of California, San Francisco, The Swedish Society of Medicine, Swedish Heart Lung Foundation, The Swedish Research Council, Swedish Council for Working Life and Social Research, Stockholm University
1. Study Identification
Unique Protocol Identification Number
NCT03551080
Brief Title
Inflammation and Brain Function - Pilot Study
Official Title
Inflammation Och hjärnfunktion - Pilotstudie
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
University of California, San Francisco, The Swedish Society of Medicine, Swedish Heart Lung Foundation, The Swedish Research Council, Swedish Council for Working Life and Social Research, Stockholm University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickness Behavior
Keywords
Sickness behavior, Cytokines, Psychoneuroimmunology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endotoxin
Arm Type
Active Comparator
Arm Description
0.8 ng lipopolysaccharide/kg body weight injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline injection
Intervention Type
Biological
Intervention Name(s)
Lipopolysaccharide
Other Intervention Name(s)
Endotoxin, LPS
Intervention Description
Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline administered intravenously
Primary Outcome Measure Information:
Title
Change in interoceptive vs exteroceptive focus
Description
Rating of concordance of heartbeat vs signal and change in tone of signal
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Change in self-rated health
Description
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
Time Frame
7 hours
Title
Change in pain perception
Description
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).
Time Frame
7 hours
Title
Change in facial apparence
Description
Photos were taken under standardised conditions before and after injection
Time Frame
2 hours
Title
Change in gait
Description
The participants were filmed walking before and after injection
Time Frame
2 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Inflammation and Brain Function - Pilot Study
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