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Completed

NCT Number: NCT03551080

Inflammation and Brain Function - Pilot Study

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipopolysaccharide

Biological

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

Other names: Endotoxin, LPS

Placebo

Biological

Saline administered intravenously

Primary outcomes

  1. Change in interoceptive vs exteroceptive focus

    Time frame: 7 hours

    Rating of concordance of heartbeat vs signal and change in tone of signal

Secondary outcomes

  1. Change in self-rated health

    Time frame: 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

  2. Change in pain perception

    Time frame: 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).

  3. Change in facial apparence

    Time frame: 2 hours

    Photos were taken under standardised conditions before and after injection

  4. Change in gait

    Time frame: 2 h

    The participants were filmed walking before and after injection

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • 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

Registry information

Official study title

Inflammation Och hjärnfunktion - Pilotstudie

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2018
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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