The Effects of Concentration/Meditation on the Innate Immune Response During Human Endotoxemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352871
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : June 7, 2011
Information provided by:
Radboud University

Brief Summary:

The innate immune response is the first line of defense against invading pathogens. Ideally, the inflammatory response is tightly regulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant or unwanted immune response such as seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic nervous system (ANS) and the innate immune response are intimately linked. Activation of the sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in some cases, sympathetic drive can also stimulate the inflammatory response via α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response as well, since it was discovered that electrical stimulation of the efferent vagus nerve in rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure autonomic which can not be influenced by behavior. However, trough special concentration/mediation techniques mastered by certain individuals, it might be possible to modulate ANS activity. In addition, recent unpublished findings indicate that these concentration/meditation techniques can also influence the inflammatory response ex vivo.

In this study the investigators wish to investigate the effect of concentration/meditation on the innate immune response in vivo. In addition the investigators wish to elucidate the mechanism via which this effect is mediated. The investigators aim to use the so called human endotoxemia model. This model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting.


Primary objective: The primary objective of the study is to determine the effect of concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS) challenge.

Secondary Objective(s):

  1. To determine the effects of concentration/meditation on ANS activity. Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve activity and plasma concentrations of catecholamines will be measured for this purpose.
  2. To determine if concentration/meditation can attenuate (subclinical) renal damage known to occur during human endotoxemia, markers of proximal and distal tubular damage will be measured at various time points.

Condition or disease Intervention/treatment
Innate Immune Response Behavioral: Concentration / meditation Drug: lipopolysaccharide

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Concentration/Meditation on the Innate Immune Response During
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Group/Cohort Intervention/treatment
Concentration / meditation
The subject will try to influence the innate immune response by concentration / meditation in advance of and during endotoxemia
Behavioral: Concentration / meditation
from 30 minutes before endotoxin administration to 1,5 hrs after endotoxin administration the subject is concentrating / meditating with the goal to influence the innate immune response

Drug: lipopolysaccharide
lipopolysaccharide 2ng/kg intravenously
Other Names:
  • LPS
  • endotoxin

Primary Outcome Measures :
  1. Change in Plasma TNF-alpha levels [ Time Frame: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration ]
    Concentration of circulating TNF-alfa at certain timepoints.

Secondary Outcome Measures :
  1. Change in plasma IL-6, IL-10 and IL-1ra levels and leukocyte counts [ Time Frame: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration ]

    circulating IL-6, IL-10 and IL-1ra levels at certain timepoints.

    Leucocyte count and differentiation will be measured

  2. Change in measures of autonomous nervous system activity [ Time Frame: at regulare intervals before and during endotoxemia ]
    • Electroencephalography (EEG)
    • Heart rate variability (HRV)
    • Plasma cathecholamines
    • Muscle sympathetic nerve activity (MSNA)

  3. Change in markers of subclinical renal tubular damage [ Time Frame: before and at 0-3, 3-6, 6-9, 9-12 and 12-24 hrs after endotoxemia ]

    determination of markers in urine collected within the above mentioned intervals.

    GSTA1-1 will be used as marker for proximal tubular damage GSTP1-1 will be used as marker for distal tubular damage

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
One healthy male volunteer that masters the concentration/meditation technique.

Inclusion Criteria:

  • 45 - 55 years of age
  • male
  • Healthy

Exclusion Criteria:

  • Use of any medication.
  • Smoking.
  • Bleeding disorder.
  • Previous spontaneous vagal collapse.
  • History, signs or symptoms of cardiovascular disease.
  • Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
  • Hypertension (defined as RR systolic > 160 or RR diastolic > 90).
  • Hypotension (defined as RR systolic < 100 or RR diastolic < 50).
  • Renal impairment (defined as plasma creatinin >120 μmol/l).
  • Liver enzyme abnormalities or positive hepatitis serology.
  • Positive HIV serology or any other obvious disease associated with immune deficiency.
  • Febrile illness in the week before the LPS challenge.
  • Participation in another drug trial or donation of blood 3 months prior to the planned LPS challenge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01352871

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6511HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Peter Pickkers, MD, PhD Radboud University

Responsible Party: Professor P. Pickkers, Principle Investigator, Radboud University Nijmegen Medical Centre Identifier: NCT01352871     History of Changes
Other Study ID Numbers: LPS-concentration
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: February 2011

Keywords provided by Radboud University:
Immunity, Innate