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

Healthy Clinical Trial

— COSI@PFC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517190
• Other study ID #: 12-024
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: August 5, 2015
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Parabolic flight

• neuro-endocrine measurements
psychic stress tests, stress hormones: prolactin, cortisol, endo-cannabinoids
• immunological measurements
blood cell counts, B2 integrins, cytokines, C-reactive protein
• cellular energy metabolism measurements
purines, lactate

Locations

Country	Name	City	State
France	Umr Ucbn/Inserm U1075 Comete	Caen CEDEX	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuro-endocrine measurements composite	prolactin, cortisol, endo-cannabinoids	baseline	No
Primary	immunological measurements composite	blood cell counts, B2 integrins, cytokines, C-reactive protein	baseline	No
Primary	cellular energy metabolism measurements composite	purines, lactate	baseline	No