Concentration/Meditation Limits Inflammation

July 22, 2013 updated by: Radboud University Medical Center

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Intensive Care Medicine, Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
LPS is used to elicit an inflammatory response in all subjects.
Other Names:
  • Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative
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
ACTIVE_COMPARATOR: Control group
Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide
LPS is used to elicit an inflammatory response in all subjects.
Other Names:
  • Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of circulating TNF-α following LPS administration
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
Time Frame: 1 day
1 day
Body temperature after LPS administration
Time Frame: 1 day
1 day
Hemodynamic parameters after LPS administration
Time Frame: 1 day
Blood pressure, heart rate, saturation, respiratory rate.
1 day
Plasma cortisol levels after LPS administration
Time Frame: 1 day
1 day
Plasma catecholamines levels after LPS administration
Time Frame: 1 day
1 day
Heart Rate Variability following LPS administration
Time Frame: 1 day
1 day
mtDNA concentrations following LPS administration
Time Frame: 1 day
1 day
Transcriptome analysis of circulating leukocytes after LPS administration
Time Frame: 1 day
1 day
Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
Time Frame: 1 day
1 day
Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
Time Frame: 1 day
1 day
effects of gut microbiome on inflammatory response elicited by LPS administration
Time Frame: 1 day
1 day
Ethylene and NO concentrations in exhaled breath after LPS administration
Time Frame: 1 day
1 day
Electrolyte concentrations in blood after concentration/meditation during endotoxemia
Time Frame: 1 day
1 day
Cortisol concentration in scalp hair
Time Frame: 1 measurement 3 weeks after LPS administration
1 measurement 3 weeks after LPS administration
Leukocyte counts and differentiation after LPS administration
Time Frame: 1 day
1 day
Illness symptoms after LPS administration
Time Frame: 1 day
shivering, headache, back ache, muscle ache, vomiting.
1 day
Blood viscosity after LPS administration
Time Frame: 1 day
1 day
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.
1 day
beta-2 glycoprotein concentrations after LPS administration
Time Frame: 1 day
1 day
cell surface markers on circulating leukocytes after LPS administration
Time Frame: 1 day
1 day
Plasma endorphin levels after LPS administration
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (ESTIMATE)

April 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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