About this trial
The goal of this single arm, interventional monocentric clinical trial is to investigate the physiological effects of a combination of head-down bedrest and caloric restriction on the human body. A set of measurements will assess the changes in the musculoskeletal, cardiovascular, hematological, immune, neurological, cognitive and metabolic systems, in 10 healthy male volunteers.
The main question it aims to answer is: what are the physiological responses to fasting in a microgravity environment?
In an exploratory study such as this one, where many physiological systems are explored, it is difficult to select a single important endpoint. However, given the known effect of both caloric restriction and head-down bedrest on muscle loss, and its critical importance for the success of space missions, lean body mass, as assessed by DEXA, was chosen as the primary endpoint.
The secondary endpoints are:
* Cardiovascular, muscular, neuro-vestibular and neuropsychological functional performance * The onset of clinical symptoms and biological changes
Participants will be exposed to a microgravity analog model (head down bed rest) and controled caloric restriction environment for 10 days, multiple physiological assessments will be performed during this period. Followed by a rehab period before leaving the study.
Eligibility criteria
Qualifiers
Healthy male volunteers (see below the description of medical tests and laboratory analysis performed at the selection visit)
Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination): in particular, free from any known chronic disease or any acute mood or eating disorder, infectious disease or cardiovascular, metabolic, neurological, ENT (especially orthostatic hypotension and vestibular disorders), orthopedic or musculoskeletal disorders.
20 to 40 years old
165 to 185 cm
Disqualifiers
Symptomatic orthostatic hypotension whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within 3 minutes when changing from the supine to the standing position
Personal or family history of thrombosis, genetic mutation for factor V or prothrombin gene
Cardiac arrhythmia
Hypertension
Trial design
Treatments tested in this trial
- head down bedrest and caloric restriction
Treatment groups
Sponsors and collaborators
Centre National d'Etudes Spatiales
Lead sponsor
MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
Collaborator