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BRAHMS: Bed Rest And HypoMetabolism Study

NCT07499167 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Microgravity
  • Caloric Restriction

Interventions

OTHER

head down bedrest and caloric restriction

the intervention is 10 days of head down bedrest (-6°) and controlled and progressive caloric restriction, then controlled and progressive refeeding

Sponsors & Collaborators

  • MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse

    collaborator UNKNOWN

  • Centre National d'Etudes Spatiales

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2026-09-28
Completion
2027-09-28

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 NCT07499167 on ClinicalTrials.gov