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临床试验/NCT01835457
NCT01835457已完成不适用

Concentration/Meditation as a Novel Means to Limit Inflammation: a Randomized Controlled Pilot Study

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Concentration of circulating TNF-α following LPS administration

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age ≥18 and ≤35 yrs
  • Travel insurance (for travel to Poland for the training in the concentration/meditation technique)

排除标准

  • Use of any medication
  • 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

研究组 & 干预措施

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

干预措施: Lipopolysaccharide (Drug)

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

干预措施: Concentration/meditation (Behavioral)

Control group

Active Comparator

Subjects in this group will be intravenously injected with 2 ng/kg Lipopolysaccharide

干预措施: Lipopolysaccharide (Drug)

结局指标

主要结局

Concentration of circulating TNF-α following LPS administration

时间窗: 1 day

次要结局

  • Circulating cytokines (including but not limited to IL-6, IL-10 and IL1RA), following LPS administration.(1 day)
  • Body temperature after LPS administration(1 day)
  • Hemodynamic parameters after LPS administration(1 day)
  • Plasma cortisol levels after LPS administration(1 day)
  • Plasma catecholamines levels after LPS administration(1 day)
  • Heart Rate Variability following LPS administration(1 day)
  • mtDNA concentrations following LPS administration(1 day)
  • Transcriptome analysis of circulating leukocytes after LPS administration(1 day)
  • Cytokine production by leukocytes ex vivo stimulated with LPS after LPS administration(1 day)
  • Changes in cell surface markers and functionality of circulating neutrophils after LPS administration(1 day)
  • effects of gut microbiome on inflammatory response elicited by LPS administration(1 day)
  • Ethylene and NO concentrations in exhaled breath after LPS administration(1 day)
  • Electrolyte concentrations in blood after concentration/meditation during endotoxemia(1 day)
  • Cortisol concentration in scalp hair(1 measurement 3 weeks after LPS administration)
  • Leukocyte counts and differentiation after LPS administration(1 day)
  • Illness symptoms after LPS administration(1 day)
  • cell surface markers on circulating leukocytes after LPS administration(1 day)
  • Blood viscosity after LPS administration(1 day)
  • Platelet-leukocyte interactions after LPS administration(1 day)
  • beta-2 glycoprotein concentrations after LPS administration(1 day)
  • Plasma endorphin levels after LPS administration(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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