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A New Nutritional Countermeasure to Prevent the Deconditioning Induced by 60 Days of Antiorthostatic Bed Rest

NCT03594799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-26

No results posted yet for this study

Summary

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A-BR2 comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the deleterious effects induced by long term physical inactivity through antiorthostatic bedrest. During a randomized 60 day bed rest study in 20 healthy male adults the two following aims will be undertaken:

* Sixteen scientific protocols will assess the changes in the cardiovascular, metabolism, muscle, bone, neuro sensorial, hematological and immunology systems.
* In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

Conditions

  • Weightlessness
  • Weightlessness; Adverse Effect

Interventions

OTHER

Bed Rest Control Group

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days.

DIETARY_SUPPLEMENT

Cocktail intervention

Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days. In addition subjects are receiving a daily supplementation of a Cocktail. The daily dose of Cocktail consists of 6 pills per day: 2 at breakfast, 2 at lunch and 2 at diner. This will be equivalent to a daily dose of around 741 mg of bioactive polyphenols associated with Omega-3, Selenium and Vitamine E.

Sponsors & Collaborators

  • European Space Agency

    collaborator OTHER

  • Centre National d'Etudes Spatiales

    lead OTHER_GOV

Principal Investigators

  • Arnaud BECK, MD · MEDES - IMPS

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594799 on ClinicalTrials.gov