Concentration/Meditation Limits Inflammation

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835457
• Other study ID #: LPS_concmed_controlled
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: July 22, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: March 2013
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Autoimmune Diseases
• Inflammation

Intervention

Drug:
• Lipopolysaccharide
LPS is used to elicit an inflammatory response in all subjects.

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).

Locations

Country	Name	City	State
Netherlands	Intensive Care Medicine, Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of circulating TNF-a following LPS administration		1 day	No
Secondary	Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.		1 day	No
Secondary	Body temperature after LPS administration		1 day	No
Secondary	Hemodynamic parameters after LPS administration	Blood pressure, heart rate, saturation, respiratory rate.	1 day	No
Secondary	Plasma cortisol levels after LPS administration		1 day	No
Secondary	Plasma catecholamines levels after LPS administration		1 day	No
Secondary	Heart Rate Variability following LPS administration		1 day	No
Secondary	mtDNA concentrations following LPS administration		1 day	No
Secondary	Transcriptome analysis of circulating leukocytes after LPS administration		1 day	No
Secondary	Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration		1 day	No
Secondary	Changes in cell surface markers and functionality of circulating neutrophils after LPS administration		1 day	No
Secondary	effects of gut microbiome on inflammatory response elicited by LPS administration		1 day	No
Secondary	Ethylene and NO concentrations in exhaled breath after LPS administration		1 day	No
Secondary	Electrolyte concentrations in blood after concentration/meditation during endotoxemia		1 day	No
Secondary	Cortisol concentration in scalp hair		1 measurement 3 weeks after LPS administration	No
Secondary	Leukocyte counts and differentiation after LPS administration		1 day	No
Secondary	Illness symptoms after LPS administration	shivering, headache, back ache, muscle ache, vomiting.	1 day	No
Secondary	Blood viscosity after LPS administration		1 day	No
Secondary	Platelet-leukocyte interactions after LPS administration	flow cytometric analysis of complexes between platelets on the one hand and monocytes, lymphocytes and neutrophils on the other hand.	1 day	No
Secondary	beta-2 glycoprotein concentrations after LPS administration		1 day	No
Secondary	cell surface markers on circulating leukocytes after LPS administration		1 day	No
Secondary	Plasma endorphin levels after LPS administration		1 day	No