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

NCT02517190 | Completed

• 1 other identifier: 12-024
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (3)

• neuro-endocrine measurements composite

  prolactin, cortisol, endo-cannabinoids

  baseline

• immunological measurements composite

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

  baseline

• cellular energy metabolism measurements composite

  purines, lactate

  baseline

Study Arms (1)

Stress response measurements

OTHER

Other: Parabolic flight; Other: neuro-endocrine measurements; Other: immunological measurements; Other: cellular energy metabolism measurements

Interventions

Parabolic flight OTHER

Stress response measurements

neuro-endocrine measurements OTHER

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

Stress response measurements

immunological measurements OTHER

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

Stress response measurements

cellular energy metabolism measurements OTHER

purines, lactate

Stress response measurements

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 6, 2015
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

FR (1)