Clinical trial NCT01835457: Concentration/Meditation Limits Inflammation
Official title: Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Diseases
Keywords: Endotoxemia
Autonomic Nervous System
Inflammation
Meditation
Concentration
Iceman
LPS
Cortisol
Catecholamines
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Concentration of circulating TNF-α following LPS administration
timeFrame: 1 day
Secondary outcomes:
measure: Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
timeFrame: 1 day
measure: Body temperature after LPS administration
timeFrame: 1 day
measure: Hemodynamic parameters after LPS administration
timeFrame: 1 day
measure: Plasma cortisol levels after LPS administration
timeFrame: 1 day
measure: Plasma catecholamines levels after LPS administration
timeFrame: 1 day
measure: Heart Rate Variability following LPS administration
timeFrame: 1 day
measure: mtDNA concentrations following LPS administration
timeFrame: 1 day
measure: Transcriptome analysis of circulating leukocytes after LPS administration
timeFrame: 1 day
measure: Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
timeFrame: 1 day
measure: Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
timeFrame: 1 day
measure: effects of gut microbiome on inflammatory response elicited by LPS administration
timeFrame: 1 day
measure: Ethylene and NO concentrations in exhaled breath after LPS administration
timeFrame: 1 day
measure: Electrolyte concentrations in blood after concentration/meditation during endotoxemia
timeFrame: 1 day
measure: Cortisol concentration in scalp hair
timeFrame: 1 measurement 3 weeks after LPS administration
measure: Leukocyte counts and differentiation after LPS administration
timeFrame: 1 day
measure: Illness symptoms after LPS administration
timeFrame: 1 day
measure: Blood viscosity after LPS administration
timeFrame: 1 day
measure: Platelet-leukocyte interactions after LPS administration
timeFrame: 1 day
measure: beta-2 glycoprotein concentrations after LPS administration
timeFrame: 1 day
measure: cell surface markers on circulating leukocytes after LPS administration
timeFrame: 1 day
measure: Plasma endorphin levels after LPS administration
timeFrame: 1 day
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Intensive Care Medicine, Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Intensive Care Medicine, Radboud University Nijmegen Medical Centre
name: M. Kox, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensive Care Medicine, Radboud University Nijmegen Medical Centre
name: P. Pickkers, MD, PhD
role: STUDY_DIRECTOR
References: