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临床试验/NCT02517190
NCT02517190已完成不适用

Effects of Repeated Short-term Microgravity During Parabolic Flight Conditions on Neuro-endocrine, Immune and Metabolic Changes

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
neuro-endocrine measurements composite

研究概览

简要总结

From previous parabolic flight campaigns completed by our research group investigators gathered data showing important changes in neuro-endocrine and also immunological changes. This experiment now will complete the data set-up obtained during the MARS500 study on how these respective individuals will re-act to highly physically and emotionally challenging situations during a parabolic flight.

This add-on experiment to MARS500 will enable answering to the following questions i) if the stress response systems - when compared for two conditions but in the same individuals - do react uniformly and ii) if those subjects prone to have adequate stress response pattern will show gradually less immune modulation effects.

The understanding of the complex interactions of stress and immunity under chronic and acute stress conditions might help to enable adequate health and immune monitoring and might as well suggest suitable countermeasures for the prevention of the unwanted immunological effects during long-term confinement and space missions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (men or women)
  • Aged from 18 to 65
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • Who participated in the MARS500 experiment
  • Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

排除标准

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Pregnant women

结局指标

主要结局

neuro-endocrine measurements composite

时间窗: baseline

prolactin, cortisol, endo-cannabinoids

immunological measurements composite

时间窗: baseline

blood cell counts, B2 integrins, cytokines, C-reactive protein

cellular energy metabolism measurements composite

时间窗: baseline

purines, lactate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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