A New Nutritional Countermeasure to Prevent the Deconditioning Induced by 60 Days of Antiorthostatic Bed Rest
Condition: Weightlessness; Weightlessness; Adverse Effect
Study type: Interventional

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.
    

Detailed description: 
      Space flights have shown the possibilities and limitations of human adaptation to space. For
      the last 50 years, results showed that the space environment and microgravity in particular,
      cause changes that may affect the performance of astronauts. These physiological changes
      particularly challenge the cardiovascular, metabolic, muscle and bone functions. Space
      agencies regularly conduct simulations on the ground on healthy volunteers to mimic the
      effects of weightlessness (head down bed rest model) to better understand the mechanisms of
      adaptations of the organism to space, and develop ways to prevent and / or reduce the
      negative biological effects of microgravity on astronauts. These protocols are called
      countermeasures. Since the beginning of space missions, various countermeasures have been
      tested on the ground and in-flight, including different exercise protocols. To date, however,
      none has been entirely satisfactory and space agencies continue to conduct simulation studies
      to evaluate new countermeasures. Nowadays, the human spaceflight program has entered the next
      phase of space exploration towards the Moon and Mars and there are clearly inherent medical
      challenges with such a goal, among which, countermeasure developments are a clear priority.

      Based on recent evidences, the next countermeasure to be tested during a 60-day bed rest
      includes a nutritional countermeasure composed of an anti-oxidant and anti-inflammatory
      dietary mix.
    

Intervention name(s): Bed Rest Control Group; Cocktail intervention
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Simulated Microgravity; Weightlessness; Countermeasure; Bedrest