BRAHMS: Bed Rest And HypoMetabolism Study (NCT07499167) | Clinical Trial Compass
RecruitingNot Applicable
BRAHMS: Bed Rest And HypoMetabolism Study
France10 participantsStarted 2026-03-10
Plain-language summary
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.
Who can participate
Age range
20 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Body Mass Index between 20 and 26 kg.m-2
* Stable body weight in the past 3 months (less than 4% change)
* Fat Mass Index (FMI), defined as (bodyfat weigh in kg)/(height in m)2: between 3 and 6 kg.m-2, measured by whole-body DEXA
* Triglyceride level under 1.7 mmol.L-1
* Normal bone mass density at left hip and lumbar spine: T-score\>-1.5, measured by DEXA
* VO2peak/VO2max between 35 and 55 mL.min-1.kg-1
* Non-smokers
* No alcohol or drug dependence, no medical treatment on a regular basis
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC).
* Free of any engagement during the study
* Who agreed to take part in the study and signed the informed consent
Exclusion Criteria:
* Any history or presence of clinically relevant chronic disease; any acute infectious disease. Particularly (but not limited to):
* Symp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lean Body Mass
Timeframe: At baseline, during the ten days of intervention and until 90 days after the end of the intervention