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Biological and Functional Markers for Precision Astronautical Biomedicine

MARS-PRE: MARcatori Biologici e Funzionali Per la Biomedicina aStronautica di PREcisione

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04081467
Acronym
MARS-PRE
Enrollment
10
Registered
2019-09-09
Start date
2019-08-28
Completion date
2019-10-16
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Atrophy

Brief summary

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.

Detailed 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.

Interventions

10-day of complete bed rest

Sponsors

University of Padova
CollaboratorOTHER
University of Bari
CollaboratorOTHER
University of Genova
CollaboratorOTHER
University of L'Aquila
CollaboratorOTHER
University of Pavia
CollaboratorOTHER
University of Trieste
CollaboratorOTHER
Humanitas Hospital, Italy
CollaboratorOTHER
University of Rome
CollaboratorUNKNOWN
Science and Research Centre Koper
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in mittochondria respiration rateAt baseline and after 10-day bed restChange in Mittochondria oxygen respiration rate per mg of muscle tissue after 10-day bed rest
Change in skeletal muscle single fibre force (in micro Newtons)At baseline and after 10-day bed restIn each aprticipants at each time point approx 10 intact muscle fibres will be studied for their force production after 10-day bed rest. Isometric muscle fibre force (in mNewton) will be measured isometric force (Fo) in four subsequent maximal activations (pCa, 4.6; sarcomere length, 2.6 micrometers; temperature 12 degrees C) using an electrical motor with force transducer mounted on it.
Change in Neurological outcomes - nerve conduction velocityAt baseline and after 10-day bed restChange in nerve conduction velocity after 10-day bed rest
Change in Neurological outcomes - fMRIAt baseline and after 10-day bed restChange in ability to mentally imagine/perform locomotory tasks (voxel-based network analyses) after 10-day bed rest
Change in Neurological outcomes - neurocognitive assessmentAt baseline and after 10-day bed restChange in EEG and neurocognitive tasks parameters (event related potential; P300 component during Stroop task) after 10-day bed rest
Change in skeletal muscle NCAM expression in single fibresBefore, at day 5 and day 10 of bed restNeural cell adhesion molecule (NCAM) expression will be analysed in vastus lateralis biopsy samples at three time points.

Secondary

MeasureTime frameDescription
Change in balance after 10-day bed restAt baseline and after 10-day bed restChange in static and dynamic balance will be assessed by functional tests (gait assessed with Optogait system and balance assessed with Tensiometric plate-COP) after 10-day bed rest
Change in muscle volume after 10-day bed restAt baseline and after 10-day bed restThigh muscle volume will be assessed by continous section obtained by 3T MRI. Muscle segmentation will done by Matlab routine.
Change in orthostatic tolerance after 10-day bed restAt baseline and after 10-day bed restChange in mean arterial pressure during supine-to-stand test (mmHg) will be assessed by supine to stand test, where subjects will stay 10 minutes in each position.
Change in peak aerobic power after 10-day bed restAt baseline and after 10-day bed restChange in peak aerobic power (maximal oxygen consumption) will be assessed on a cycloergometer using graded load protocol.
Nonhomogeneous change in skeletal muscle pennation angle after 10-day bed restAt baseline, every 2 days of bed rest and after 10-day bed restChange in Muscle architecture will be assessed in vastus lateralis, biceps femoris, tibialis anterior, multifidus using sonography. Specifically, we will assess all three architecture parameters (pennation angle, fascicle length and thickness), however for the purspose of this outcome we hypothesize non-homogenous change throughout the whole muscles in pennation angle. The assessment will be performed before, every 2 days of bed rest and post bed rest.
Change in maximal displacement after twitch contraction after 10-day bed restAt baseline, every 2 days of bed rest and after 10-day bed restUsing tensiomyography we will assess contraction time and maximal discplacement in vastus lateralis, tibialis anterior, biceps femoris, multifidus muscles. We expect that contraction time will remained the same but maximal diasplacement - a measure of a muscle tone, will increase much before the changes in muscle thickness - assessed by sonography. The assessment will be performed before, every 2 days of bed rest and post bed rest.
Change in skeletal composition after 10-day bed restAt baseline, day 5 and after 10-day bed restUsing electrophoresis we will assess changes in myosing heavy chains somposition in the biopsies obtained from vastus lateralis muscle before, at day 5 and post 10 days of bed rest
Change in skeletal muscle maximal voluntary contraction after 10-day bed restAt baseline and after 10-day bed restMaximal voluntary isometric knee extensors contraction will be measured using dnamometer set at 90 deg flexion.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026