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

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in concentration of circulating TNF-a<br /><br>following LPS administration between the concentration/meditation group and the<br /><br>control group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include other circulating cytokines (IL-6, IL-10 and<br /><br>IL1RA), body temperature, hemodynamics, cortisol, catecholamines, heart rate<br /><br>variability, and blood gas parameters.</p><br>