Effects of a certain concentration/meditation technique on inflammation.

Phase 1

• Conditions: Possibe future indications: inflammatory conditions in general, auto-immune diseases; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-004622-14-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-19
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

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

-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 <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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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