Concentration/Meditation Limits Inflammation

NCT01835457 | Completed DMC

• 1 other identifier: LPS_concmed_controlled
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases

Keywords

Endotoxemia; Autonomic Nervous System; Inflammation; Meditation; Concentration; Iceman; LPS; Cortisol; Catecholamines

Outcome Measures

Primary Outcomes (1)

• Concentration of circulating TNF-α following LPS administration

  1 day

Secondary Outcomes (21)

• Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.

  1 day

• Body temperature after LPS administration

  1 day

• Hemodynamic parameters after LPS administration

  1 day

• Plasma cortisol levels after LPS administration

  1 day

• Plasma catecholamines levels after LPS administration

  1 day

Study Arms (2)

Concentration/meditation group

EXPERIMENTAL

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; Behavioral: Concentration/meditation

Control group

ACTIVE COMPARATOR

Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide

Drug: Lipopolysaccharide

Interventions

Lipopolysaccharide DRUG

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

Also known as: Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative

Concentration/meditation group; Control group

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).

Also known as: Wim Hof Method

Concentration/meditation group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 and ≤35 yrs
• Male
• Healthy
• Travel insurance (for travel to Poland for the training in the concentration/meditation technique)

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Intensive Care Medicine, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Autoimmune Diseases; Endotoxemia; Inflammation

Interventions

Lipopolysaccharides; Meditation

Condition Hierarchy (Ancestors)

Immune System Diseases; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Biological Factors; Endotoxins; Bacterial Toxins; Toxins, Biological; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• M. Kox, Dr.

  Intensive Care Medicine, Radboud University Nijmegen Medical Centre

  PRINCIPAL INVESTIGATOR

• P. Pickkers, MD, PhD

  Intensive Care Medicine, Radboud University Nijmegen Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 19, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 23, 2013

Record last verified: 2013-03

Locations

NL (1)