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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Parabolic flight; Other: neuro-endocrine measurements; Other: immunological measurements; Other: cellular energy metabolism measurements

• Registration Number: NCT02517190
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2015-07-23
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress response measurements	immunological measurements	-
Stress response measurements	cellular energy metabolism measurements	-
Stress response measurements	Parabolic flight	-
Stress response measurements	neuro-endocrine measurements	-

Primary Outcome Measures

Name	Time	Method
neuro-endocrine measurements composite	baseline	prolactin, cortisol, endo-cannabinoids
immunological measurements composite	baseline	blood cell counts, B2 integrins, cytokines, C-reactive protein
cellular energy metabolism measurements composite	baseline	purines, lactate

Trial Locations

Locations (1)

Umr Ucbn/Inserm U1075 Comete; 🇫🇷 Caen CEDEX, Basse-Normandie, France