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Completed

NCT Number: NCT01835457

Concentration/Meditation Limits Inflammation

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Medicine, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

lipopolysaccharide

Drug

LPS is used to elicit an inflammatory response in all subjects.

Other names: Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative

Concentration/meditation

Behavioral

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 names: Wim Hof Method

Primary outcomes

  1. Concentration of circulating TNF-α following LPS administration

    Time frame: 1 day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2013
Registry last updated
Jul 23, 2013

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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