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临床试验/NCT03551080
NCT03551080已完成不适用

Inflammation Och hjärnfunktion - Pilotstudie

Karolinska Institutet0 个研究点目标入组 8 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Change in interoceptive vs exteroceptive focus

研究概览

简要总结

In this randomized double blind cross-over study 8 healthy persons were injected with 0.8 ng/kg body weight lipopolysaccharide (LPS) /endotoxin and placebo at two different occasions. The aim was to investigate how pain sensitivity and health perception change in response to an acute immune activation.

详细描述

Eight healthy participants were included in this randomized and balanced double blind cross-over study. They were injected two times, once with the active component and once with placebo. Participants were recruited by advertising and screened through questionnaires and a health examination by a physician. They were asked not to engage in strenuous physical activities, sleep regular hours and refrain from alcohol the day before the experiment. If the participants felt ill, e.g. coming down with a cold, they were instructed to call and were rescheduled for a later appointment. C-reactive protein (CRP) was assessed to exclude participants having an ongoing infection on the experimental day. Pregnancy was also an exclusion criteria and a pregnancy test was administered for all female participants on arrival. Several pain sensitivity measures were performed baseline and at peak inflammatory response 1-2 hours after injection. Subjects filled out questionnaires at baseline, 90 minutes and 4,5 hours after injection.

The study and the procedures used in the study are described in detail here: https://openarchive.ki.se/xmlui/bitstream/handle/10616/44650/Thesis\_Bianka\_Karshikoff.pdf?sequence=8\&isAllowed=y

The following papers have been published using data from this study:

Olsson MJ, Lundstrom JN, Kimball BA, Gordon AR, Karshikoff B, Hosseini N, Sorjonen K, Olgart Hoglund C, Solares C, Soop A, Axelsson J & Lekander M. The Scent of Disease: Human Body Odor Contains an Early Chemosensory Cue of Sickness. Psychol Sci. 2014 Jan 22.

Sundelin T, Karshikoff B, Axelsson E, Hoglund CO, Lekander M, Axelsson J. Sick man walking: Perception of health status from body motion. Brain Behav Immun. 2015;48:53-6.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects

排除标准

  • •Diagnosed physiological or psychiatric disease
  • •Needle anxiety or blood phobia
  • •Regular medication (excluding contraceptive pill)
  • •Infection in the last two weeks
  • •Pregnancy or breastfeeding
  • •Excessive alcohol use
  • •Body mass index in the range of obesity (>30 kg/m2) or underweight (<18.5 kg/m2)
  • •Invisible veins in the antecubital area of the arms

研究组 & 干预措施

Endotoxin

Active Comparator

0.8 ng lipopolysaccharide/kg body weight injection

干预措施: Lipopolysaccharide (Biological)

Placebo

Placebo Comparator

Saline injection

干预措施: Placebo (Biological)

结局指标

主要结局

Change in interoceptive vs exteroceptive focus

时间窗: 7 hours

Rating of concordance of heartbeat vs signal and change in tone of signal

次要结局

  • Change in facial apparence(2 hours)
  • Change in self-rated health(7 hours)
  • Change in pain perception(7 hours)
  • Change in gait(2 h)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mats Lekander

Professor

Karolinska Institutet

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