Inflammation and Brain Function - Pilot Study

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03551080
Collaborator
University of California, San Francisco (Other), The Swedish Society of Medicine (Other), Swedish Heart Lung Foundation (Other), The Swedish Research Council (Other), Swedish Council for Working Life and Social Research (Other), Stockholm University (Other)
8
2
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Lipopolysaccharide
  • Biological: Placebo
N/A

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?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

  1. Modality and sex differences in pain sensitivity during human endotoxemia. Brain, Behavior, and Immunity. 2015 May;46:35-43

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
Inflammation Och hjärnfunktion - Pilotstudie
Actual Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Endotoxin

0.8 ng lipopolysaccharide/kg body weight injection

Biological: Lipopolysaccharide
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 Comparator: Placebo

    Saline injection

    Biological: Placebo
    Saline administered intravenously

    Outcome Measures

    Primary Outcome Measures

    1. Change in interoceptive vs exteroceptive focus [7 hours]

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

    Secondary Outcome Measures

    1. 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

    2. 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).

    3. Change in facial apparence [2 hours]

      Photos were taken under standardised conditions before and after injection

    4. Change in gait [2 h]

      The participants were filmed walking before and after injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karolinska Institutet
    • 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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mats Lekander, Professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT03551080
    Other Study ID Numbers:
    • 2008/955-31
    First Posted:
    Jun 11, 2018
    Last Update Posted:
    Jun 11, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mats Lekander, Professor, Karolinska Institutet
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 11, 2018