Effects of a certain concentration/meditation technique on inflammation.

Concentration/meditation as a novel means to limit inflammation: a randomized controlled pilot study - Concentration/meditation limits inflammation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004622-14-NL

Enrollment

Registered

2012-10-19

Start date

2013-02-01

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Possibe future indications: inflammatory conditions in general, auto-immune diseases

Interventions

Product Name: Lipopolysaccharide Product Code: LPS Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: lipopolysaccharide Current Sponsor code: LPS Concentration unit: µg micro

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Age =18 and =35 yrs - Male - Healthy - Travel insurance (for travel to Poland) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Use of any medication - Smoking - Use of recreational drugs within 21 days prior to endotoxemia experiment day - Use of caffeine or alcohol or 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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to determine the effect of practicing the iceman’s concentration/meditation technique on the inflammatory response during human endotoxemia (lipopolysaccharide [LPS] administration in healthy volunteers).;Secondary Objective: Secondary objectives are 1. To determine the effects of concentration/meditation on autonomic nervous system activity. 2. To determine the effects of the concentration/meditation technique on blood gas parameters.;Primary end point(s): The main study endpoint is the difference in circulating TNF-a following LPS administration between the concentration/meditation group and the control group. ;Timepoint(s) of evaluation of this end point: 0, 30, 60, 90, 120, 180, 240, 360, and 480 minutes after LPS administration.	—

Measure

Time frame

Main Objective: The main objective of the study is to determine the effect of practicing the iceman’s concentration/meditation technique on the inflammatory response during human endotoxemia (lipopolysaccharide [LPS] administration in healthy volunteers).;Secondary Objective: Secondary objectives are 1. To determine the effects of concentration/meditation on autonomic nervous system activity. 2. To determine the effects of the concentration/meditation technique on blood gas parameters.;Primary end point(s): The main study endpoint is the difference in circulating TNF-a following LPS administration between the concentration/meditation group and the control group. ;Timepoint(s) of evaluation of this end point: 0, 30, 60, 90, 120, 180, 240, 360, and 480 minutes after LPS administration.

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Secondary

Measure	Time frame
Secondary end point(s): - Other circulating cytokines (IL-6, IL-10 and IL1RA) - Body temperature - Hemodynamic parameters (heart rate, blood pressure) - Leukocyte counts and differentiation - Catecholamines (adrenaline and noradrenaline) - Heart rate variability parameters as a measure of autonomic nervous system activity - Blood gas parameters ;Timepoint(s) of evaluation of this end point: At various time-points or continuous between -30 and 480 minutes after LPS administration	—

Measure

Time frame

Secondary end point(s): - Other circulating cytokines (IL-6, IL-10 and IL1RA) - Body temperature - Hemodynamic parameters (heart rate, blood pressure) - Leukocyte counts and differentiation - Catecholamines (adrenaline and noradrenaline) - Heart rate variability parameters as a measure of autonomic nervous system activity - Blood gas parameters ;Timepoint(s) of evaluation of this end point: At various time-points or continuous between -30 and 480 minutes after LPS administration

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Countries

Netherlands

Contacts

Public ContactMatthijs Kox

Radboud University Nijmegen Medical Centre

m.kox@anes.umcn.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026