Biological and Functional Markers for Precision Astronautical Biomedicine (MARS-PRE)

Science and Research Centre Koper

Status: Completed

Conditions: Muscular Atrophy

Treatments: Other: Bed rest

Study type: Interventional

Funder types: Other

Identifiers

NCT04081467

BR2019 MARS-PRE

Details and patient eligibility

About

In the current study the investigators will study early biomarkers of human degradation. In 10-day horizontal bed rest the investigators will enroll 10 healthy male subjects (18-30years, BMI 20-28kg/m2). Pre-, mid- and post-bed rest the investigators will perform various measurements, some of them will be invasive (blood samples and muscle biopsies), which will be carefully taken by the medical staff. The subjects will be placed in hospital rooms and have 24-hour medical supervision, adequate hygiene, nutrition, passive exercise, entertainment and visits.

Full description

Ten young male participants will undergo 10 days of horizontal bed rest. Before, during and after the investigators will monitor many biomechanical, metabolic, cardiovascular, biochemical responses.

During the bed rest period there will be no interventions. subjects will be allowed to rotate freely, with no vertical stimulus of any-kind.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index between 20 - 28 kg/m2
• male participants
• a healthy individual who is able to complete all the tests planned in the research protocol

Exclusion criteria

• smoking;
• regular alcohol consumption;
• ferromagnetic implants;
• history of deep vein thrombosis with D-dimer > 500 μg·L-1;
• acute or chronic skeletal, neuromuscular, psychological, metabolic and cardiovascular disease conditions.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

bed rest condition

Experimental group

Description:

Bed rest condition without any additional intervention

Treatment:

Other: Bed rest