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Completed

NCT Number: NCT02517190

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Parabolic flight

Other

neuro-endocrine measurements

Other

psychic stress tests, stress hormones: prolactin, cortisol, endo-cannabinoids

immunological measurements

Other

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

cellular energy metabolism measurements

Other

purines, lactate

Primary outcomes

  1. neuro-endocrine measurements composite

    Time frame: baseline

    prolactin, cortisol, endo-cannabinoids

  2. immunological measurements composite

    Time frame: baseline

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

  3. cellular energy metabolism measurements composite

    Time frame: baseline

    purines, lactate

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: COSI@PFC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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