Autoimmune DiseasesNCT01835457
Concentration/Meditation Limits Inflammation
A study testing Lipopolysaccharide and Concentration/meditation in people with Autoimmune Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Lipopolysaccharide and Concentration/meditation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and ≤35 yrs
- Male
- Healthy
- Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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.
- Conditions
- Autoimmune Diseases
- Being tested
- Lipopolysaccharide, Concentration/meditation
- Keywords
- Endotoxemia, Autonomic Nervous System, Inflammation, Meditation, Concentration, Iceman, LPS, Cortisol, Catecholamines
- Medical subject headings
- Autoimmune Diseases, Endotoxemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipopolysaccharideDrug
Also called Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative
LPS is used to elicit an inflammatory response in all subjects.
Concentration/meditationBehavioural
Also called Wim Hof Method
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lipopolysaccharide; Behavioral: Concentration/meditation |
| Control group | Active comparator | Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide Receives: Drug: Lipopolysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of circulating TNF-α following LPS administration
Measured: 1 day
Secondary outcomes (21)
Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
Measured: 1 day
Body temperature after LPS administration
Measured: 1 day
Hemodynamic parameters after LPS administration
Blood pressure, heart rate, saturation, respiratory rate.
Measured: 1 day
Plasma cortisol levels after LPS administration
Measured: 1 day
Plasma catecholamines levels after LPS administration
Measured: 1 day
Heart Rate Variability following LPS administration
Measured: 1 day
mtDNA concentrations following LPS administration
Measured: 1 day
Transcriptome analysis of circulating leukocytes after LPS administration
Measured: 1 day
Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
Measured: 1 day
Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
Measured: 1 day
effects of gut microbiome on inflammatory response elicited by LPS administration
Measured: 1 day
Ethylene and NO concentrations in exhaled breath after LPS administration
Measured: 1 day
Electrolyte concentrations in blood after concentration/meditation during endotoxemia
Measured: 1 day
Cortisol concentration in scalp hair
Measured: 1 measurement 3 weeks after LPS administration
Leukocyte counts and differentiation after LPS administration
Measured: 1 day
Illness symptoms after LPS administration
shivering, headache, back ache, muscle ache, vomiting.
Measured: 1 day
Blood viscosity after LPS administration
Measured: 1 day
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.
Measured: 1 day
beta-2 glycoprotein concentrations after LPS administration
Measured: 1 day
cell surface markers on circulating leukocytes after LPS administration
Measured: 1 day
Plasma endorphin levels after LPS administration
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Kox, Dr., Principal investigator, Intensive Care Medicine, Radboud University Nijmegen Medical CentreP. Pickkers, MD, PhD, Study director, Intensive Care Medicine, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835457
- Sponsor's protocol ID
- LPS_concmed_controlled
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01835457
- Acronym / sponsor ID
- LPS_concmed_controlled
- Conditions
- Autoimmune Diseases
- Keywords
- Endotoxemia, Autonomic Nervous System, Inflammation, Meditation, Concentration, Iceman, LPS, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentration/meditation group | Experimental | Drug: Lipopolysaccharide, Behavioral: Concentration/meditationSubjects 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 |
| Control group | Active comparator | Drug: LipopolysaccharideSubjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥18 and ≤35 yrs
- Male
- Healthy
- Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipopolysaccharideAlso: Lipopolysaccharide (LPS) E. Coli 113:H 10:K negativeLPS is used to elicit an inflammatory response in all subjects. | Drug | Concentration/meditation group, Control group |
| Concentration/meditationAlso: Wim Hof MethodA 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). | Behavioural | Concentration/meditation group |
Primary outcome
Concentration of circulating TNF-α following LPS administration
Time frame: 1 day
21 secondary outcomes
Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.
Time frame: 1 day
Body temperature after LPS administration
Time frame: 1 day
Hemodynamic parameters after LPS administration
Time frame: 1 day
Plasma cortisol levels after LPS administration
Time frame: 1 day
Plasma catecholamines levels after LPS administration
Time frame: 1 day
Heart Rate Variability following LPS administration
Time frame: 1 day
mtDNA concentrations following LPS administration
Time frame: 1 day
Transcriptome analysis of circulating leukocytes after LPS administration
Time frame: 1 day
Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration
Time frame: 1 day
Changes in cell surface markers and functionality of circulating neutrophils after LPS administration
Time frame: 1 day
effects of gut microbiome on inflammatory response elicited by LPS administration
Time frame: 1 day
Ethylene and NO concentrations in exhaled breath after LPS administration
Time frame: 1 day
Electrolyte concentrations in blood after concentration/meditation during endotoxemia
Time frame: 1 day
Cortisol concentration in scalp hair
Time frame: 1 measurement 3 weeks after LPS administration
Leukocyte counts and differentiation after LPS administration
Time frame: 1 day
Illness symptoms after LPS administration
Time frame: 1 day
Blood viscosity after LPS administration
Time frame: 1 day
Platelet-leukocyte interactions after LPS administration
Time frame: 1 day
beta-2 glycoprotein concentrations after LPS administration
Time frame: 1 day
cell surface markers on circulating leukocytes after LPS administration
Time frame: 1 day
Plasma endorphin levels after LPS administration
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Kox, Dr. principal investigator
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
P. Pickkers, MD, PhD study director
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipopolysaccharide and Concentration/meditation in people with Autoimmune Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of circulating TNF-α following LPS administration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.