BRAHMS: Bed Rest And HypoMetabolism Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-40
SponsorCentre National d'Etudes Spatiales
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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
head down bedrest and caloric restriction
Other interventionthe intervention is 10 days of head down bedrest (-6°) and controlled and progressive caloric restriction, then controlled and progressive refeeding
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Caloric restrictionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lean Body Mass
Lean Body Mass assessed by dual energy x-ray absorptiometry (DEXA)
Time frame
At baseline, during the ten days of intervention and until 90 days after the end of the interventionSecondary outcomes
1
Change in body fluid compartments by bioelectrical impedance analysis
Extracellular, intracellular and total body water (L) will be estimated by bioimpedance
Time frame
At baseline, during the ten days of intervention and until 90 days after the end of the intervention2
Change in whole-body Magnetic Resonance Imaging (MRI)
Change in MRI-measured whole-body Lean mass (kg) and Fat mass (kg) will be estimated
Time frame
At baseline and at day 9 of intervention period3
Change in mood
Change in mood is assessed using the Profile of Mood States (POMS) questionnaire. POMS questionnaire gives 6 measures of mood: Tension/anxiety, Depression, Anger/hostility Dynamism, Fatigue, Confusion A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales (tension, depression, fatigue, confusion, anger) and then subtracting the totals for the positive subscale (vigor /esteem-related affect).
Time frame
At baseline, during the ten days of intervention and until 4 days after the end of the intervention4
Assessment of movements by volunteers
Actigraphs attached to wristbands placed on the non-dominant wrist and ankle of each volunteer
Time frame
At baseline, during the ten days of the intervention and until 4 days after the end of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre National d'Etudes Spatiales
Lead sponsor
MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
Collaborator
Source ClinicalTrials.gov