Concentration/Meditation Limits Inflammation
Primary Purpose
Autoimmune Diseases
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lipopolysaccharide
Concentration/meditation
Sponsored by
![Radboud University Medical Center](https://trials-media.s3.amazonaws.com/orgs/radboud-university-medical-center.jpeg)
About this trial
This is an interventional basic science trial for Autoimmune Diseases focused on measuring Endotoxemia, Autonomic Nervous System, Inflammation, Meditation, Concentration, Iceman, LPS, Cortisol, Catecholamines
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 and ≤35 yrs
- Male
- Healthy
- Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Exclusion Criteria:
- Use of any medication
- Smoking
- Use of recreational drugs within 21 days prior to endotoxemia experiment day
- Use of caffeine or alcohol within 1 day prior to endotoxemia experiment day
- Previous participation in a trial where LPS was administered
- Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day
- Participation in another clinical trial within 3 months prior to endotoxemia experiment day.
- History, signs, or symptoms of cardiovascular disease
- History of frequent vaso-vagal collapse or of orthostatic hypotension
- History of atrial or ventricular arrhythmia
- Hypertension (RR systolic >160 or RR diastolic >90)
- Hypotension (RR systolic <100 or RR diastolic <50)
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
- Renal impairment: plasma creatinine >120 µmol/L
- Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L
- History of asthma
- Obvious disease associated with immune deficiency.
- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
Sites / Locations
- Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Concentration/meditation group
Control group
Arm Description
Subjects in this arm will be performing the concentration/meditation technique of Wim Hof (The Iceman) prior to, during and after intravenously injected 2 ng/kg Lipopolysaccharide
Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide
Outcomes
Primary Outcome Measures
Concentration of circulating TNF-α following LPS administration
Secondary Outcome Measures
Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
Body temperature after LPS administration
Hemodynamic parameters after LPS administration
Blood pressure, heart rate, saturation, respiratory rate.
Plasma cortisol levels after LPS administration
Plasma catecholamines levels after LPS administration
Heart Rate Variability following LPS administration
mtDNA concentrations following LPS administration
Transcriptome analysis of circulating leukocytes after LPS administration
Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
effects of gut microbiome on inflammatory response elicited by LPS administration
Ethylene and NO concentrations in exhaled breath after LPS administration
Electrolyte concentrations in blood after concentration/meditation during endotoxemia
Cortisol concentration in scalp hair
Leukocyte counts and differentiation after LPS administration
Illness symptoms after LPS administration
shivering, headache, back ache, muscle ache, vomiting.
Blood viscosity after LPS administration
Platelet-leukocyte interactions after LPS administration
flow cytometric analysis of complexes between platelets on the one hand and monocytes, lymphocytes and neutrophils on the other hand.
beta-2 glycoprotein concentrations after LPS administration
cell surface markers on circulating leukocytes after LPS administration
Plasma endorphin levels after LPS administration
Full Information
NCT ID
NCT01835457
First Posted
March 25, 2013
Last Updated
July 22, 2013
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01835457
Brief Title
Concentration/Meditation Limits Inflammation
Official Title
Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Auto-immune diseases are characterized by an inappropriate inflammatory response against tissues in the body and represent a major health care burden. Pro-inflammatory cytokines such as TNF-α, IL-6 and IL-1β play a central role in the pathophysiology of many auto-immune diseases. Innovative therapies aimed at limiting pro-inflammatory cytokine production in a more physiological manner are warranted. In previous research conducted in an individual known as "the iceman", the investigators found that, through a autodidact concentration/meditation technique, he appears to mount a controlled stress response, characterized by activation of the sympathetic nervous system and enhanced production of cortisol, both of which are known to result in immunosuppression. In accordance, while practicing this concentration/meditation technique, the inflammatory response during human endotoxemia (lipopolysaccharide [LPS] administration) was remarkably low in this individual. Therefore, this technique could provide a novel means of controlling the inflammatory response. However, the aforementioned results were obtained in just one subject, and hence can not serve as scientific evidence for the effectiveness of the concentration/meditation technique. The iceman claims that he can teach this technique to other subjects within a relatively short time frame. Therefore, in the present study the investigators wish to investigate the effect of concentration/meditation on autonomic nervous system activity and the inflammatory response during experimental human endotoxemia in a controlled manner, by comparing a group of subjects that are trained by "the iceman" and practice the concentration/meditation technique with a group of subjects which do not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases
Keywords
Endotoxemia, Autonomic Nervous System, Inflammation, Meditation, Concentration, Iceman, LPS, Cortisol, Catecholamines
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concentration/meditation group
Arm Type
Experimental
Arm Description
Subjects in this arm will be performing the concentration/meditation technique of Wim Hof (The Iceman) prior to, during and after intravenously injected 2 ng/kg Lipopolysaccharide
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide
Intervention Type
Drug
Intervention Name(s)
Lipopolysaccharide
Other Intervention Name(s)
Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative
Intervention Description
LPS is used to elicit an inflammatory response in all subjects.
Intervention Type
Behavioral
Intervention Name(s)
Concentration/meditation
Other Intervention Name(s)
Wim Hof Method
Intervention Description
A self-taught concentration/meditation technique that Mr Wim Hof developed himself, characterized by cycles consisting of a few minutes of hyperventilation followed by breath holding for up to 1-2 minutes and deep concentration (mindset).
Primary Outcome Measure Information:
Title
Concentration of circulating TNF-α following LPS administration
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
Time Frame
1 day
Title
Body temperature after LPS administration
Time Frame
1 day
Title
Hemodynamic parameters after LPS administration
Description
Blood pressure, heart rate, saturation, respiratory rate.
Time Frame
1 day
Title
Plasma cortisol levels after LPS administration
Time Frame
1 day
Title
Plasma catecholamines levels after LPS administration
Time Frame
1 day
Title
Heart Rate Variability following LPS administration
Time Frame
1 day
Title
mtDNA concentrations following LPS administration
Time Frame
1 day
Title
Transcriptome analysis of circulating leukocytes after LPS administration
Time Frame
1 day
Title
Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
Time Frame
1 day
Title
Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
Time Frame
1 day
Title
effects of gut microbiome on inflammatory response elicited by LPS administration
Time Frame
1 day
Title
Ethylene and NO concentrations in exhaled breath after LPS administration
Time Frame
1 day
Title
Electrolyte concentrations in blood after concentration/meditation during endotoxemia
Time Frame
1 day
Title
Cortisol concentration in scalp hair
Time Frame
1 measurement 3 weeks after LPS administration
Title
Leukocyte counts and differentiation after LPS administration
Time Frame
1 day
Title
Illness symptoms after LPS administration
Description
shivering, headache, back ache, muscle ache, vomiting.
Time Frame
1 day
Title
Blood viscosity after LPS administration
Time Frame
1 day
Title
Platelet-leukocyte interactions after LPS administration
Description
flow cytometric analysis of complexes between platelets on the one hand and monocytes, lymphocytes and neutrophils on the other hand.
Time Frame
1 day
Title
beta-2 glycoprotein concentrations after LPS administration
Time Frame
1 day
Title
cell surface markers on circulating leukocytes after LPS administration
Time Frame
1 day
Title
Plasma endorphin levels after LPS administration
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18 and ≤35 yrs
Male
Healthy
Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Exclusion Criteria:
Use of any medication
Smoking
Use of recreational drugs within 21 days prior to endotoxemia experiment day
Use of caffeine or alcohol within 1 day prior to endotoxemia experiment day
Previous participation in a trial where LPS was administered
Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day
Participation in another clinical trial within 3 months prior to endotoxemia experiment day.
History, signs, or symptoms of cardiovascular disease
History of frequent vaso-vagal collapse or of orthostatic hypotension
History of atrial or ventricular arrhythmia
Hypertension (RR systolic >160 or RR diastolic >90)
Hypotension (RR systolic <100 or RR diastolic <50)
Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
Renal impairment: plasma creatinine >120 µmol/L
Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L
History of asthma
Obvious disease associated with immune deficiency.
CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Kox, Dr.
Organizational Affiliation
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. Pickkers, MD, PhD
Organizational Affiliation
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
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