- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835457
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
Status
Completed
Conditions
Intervention / Treatment
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:
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:
|
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:
|
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPS_concmed_controlled
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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