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Inflammation and Brain Function - Pilot Study

Primary Purpose

Sickness Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lipopolysaccharide
Placebo
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sickness Behavior focused on measuring Sickness behavior, Cytokines, Psychoneuroimmunology

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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