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

NCT ID: NCT02517190

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Stress response measurements

Group Type OTHER

Parabolic flight

Intervention Type OTHER

neuro-endocrine measurements

Intervention Type OTHER

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

immunological measurements

Intervention Type OTHER

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

cellular energy metabolism measurements

Intervention Type OTHER

purines, lactate

Interventions

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Parabolic flight

Intervention Type OTHER

neuro-endocrine measurements

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

Intervention Type OTHER

immunological measurements

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

Intervention Type OTHER

cellular energy metabolism measurements

purines, lactate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, France

Site Status

Countries

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France

Other Identifiers

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12-024

Identifier Type: -

Identifier Source: org_study_id

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