Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concentration/Meditation Limits Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835457
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Drug: Lipopolysaccharide Behavioral: Concentration/meditation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Concentration/meditation group
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
 Drug: Lipopolysaccharide
LPS is used to elicit an inflammatory response in all subjects.
Other Name: Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative

Behavioral: Concentration/meditation
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).
Other Name: Wim Hof Method
Active Comparator: Control group
Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide
 Drug: Lipopolysaccharide
LPS is used to elicit an inflammatory response in all subjects.
Other Name: Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Concentration of circulating TNF-α following LPS administration [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration. [ Time Frame: 1 day ]
  2. Body temperature after LPS administration [ Time Frame: 1 day ]
  3. Hemodynamic parameters after LPS administration [ Time Frame: 1 day ]
    Blood pressure, heart rate, saturation, respiratory rate.

  4. Plasma cortisol levels after LPS administration [ Time Frame: 1 day ]
  5. Plasma catecholamines levels after LPS administration [ Time Frame: 1 day ]
  6. Heart Rate Variability following LPS administration [ Time Frame: 1 day ]
  7. mtDNA concentrations following LPS administration [ Time Frame: 1 day ]
  8. Transcriptome analysis of circulating leukocytes after LPS administration [ Time Frame: 1 day ]
  9. Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration [ Time Frame: 1 day ]
  10. Changes in cell surface markers and functionality of circulating neutrophils after LPS administration [ Time Frame: 1 day ]
  11. effects of gut microbiome on inflammatory response elicited by LPS administration [ Time Frame: 1 day ]
  12. Ethylene and NO concentrations in exhaled breath after LPS administration [ Time Frame: 1 day ]
  13. Electrolyte concentrations in blood after concentration/meditation during endotoxemia [ Time Frame: 1 day ]
  14. Cortisol concentration in scalp hair [ Time Frame: 1 measurement 3 weeks after LPS administration ]
  15. Leukocyte counts and differentiation after LPS administration [ Time Frame: 1 day ]
  16. Illness symptoms after LPS administration [ Time Frame: 1 day ]
    shivering, headache, back ache, muscle ache, vomiting.

  17. Blood viscosity after LPS administration [ Time Frame: 1 day ]
  18. Platelet-leukocyte interactions after LPS administration [ Time Frame: 1 day ]
    flow cytometric analysis of complexes between platelets on the one hand and monocytes, lymphocytes and neutrophils on the other hand.

  19. beta-2 glycoprotein concentrations after LPS administration [ Time Frame: 1 day ]
  20. cell surface markers on circulating leukocytes after LPS administration [ Time Frame: 1 day ]
  21. Plasma endorphin levels after LPS administration [ Time Frame: 1 day ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835457


Locations
Layout table for location information
Netherlands
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: M. Kox, Dr. Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Study Director: P. Pickkers, MD, PhD Intensive Care Medicine, Radboud University Nijmegen Medical Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01835457    
Other Study ID Numbers: LPS_concmed_controlled
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: March 2013
Keywords provided by Radboud University Medical Center:
Endotoxemia
Autonomic Nervous System
Inflammation
Meditation
Concentration
 Iceman
LPS
Cortisol
Catecholamines
Additional relevant MeSH terms:
Layout table for MeSH terms
Autoimmune Diseases
Inflammation
Pathologic Processes
Immune System Diseases