Skip to main content
OpenTrials
Completed

NCT Number: NCT06141291

Bed Rest Study SBI 2023

The study will consist of three groups of subjects. Ten young male subjects (18-30 years) will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days, and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but will receive interventions (see below) to counteract the physical changes caused by supine lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After their stay, subjects return home but receive 21 days of care at local fitness centers. Rehabilitation consists of interval training, in which subjects perform high-intensity exercise for 4 times 5 minutes. A number of important health parameters are measured before, during, and after bed rest. Some of these measurements will be invasive (blood and muscle sampling), for which appropriate medical personnel, sterile instruments, and environment will be available. Measurements will include normal voluntary efforts (indoor cycling, various jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation with single impulses). All tests are normal tests and come from normal lifestyles and routine medical examinations.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Aging Behavior Physical Inactivity Sedentary Behavior

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SRC Koper

Koper, 6000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age: for young arm (18-35), for old arm (65-75)
  • BMI: 22 in 32 kg/m2
  • appendicular muscle mass > 7,23 kg/m2

Exclusion criteria

  • serious acute or chronic diseases: skeletal, cancer, cardiovascular, metabolic, neuromuscular and psychiatric;
  • cardiovascular disease detected on ECG examination;
  • allergies to the active substances used in the study;
  • problems with digestion of the active substances;
  • frequent diarrhea and vomiting;
  • arterial hypertension (>140/90 mmHg);
  • psychological problems;
  • susceptibility to deep vein thrombosis (D-dimer < 500 μg/L)
  • poor orthostatic tolerance (frequent dizziness when changing position, especially when rising from a supine position);
  • venous abnormalities that would cause difficulty in drawing blood;
  • a large blood volume (more than 300 ml) in the last 3 months prior to the start of the project;
  • problems with excessive consumption of alcoholic beverages;
  • active smoking;
  • Previous participation in any biomedical research in the last 3 months prior to the start of this study;
  • a communicable disease before the start of the project;
  • any ferromagnetic implant.

Treatment and study plan

high protein diet

Dietary Supplement

Test the ability of high protein diet (1.4 g protein/kg/day) with branched chain amino acid and cysteine supplementation to decrease bed rest induced muscle atrophy, glutathione depletion and insulin resistance in old subjects.

OGTT

Diagnostic Test

Assessment of changes in insulin sensitivity (Oral Glucose Tolerance test and muscle insulin signalling: immunofluorescence and western blot of GLUT-4, IRS-1, MPP/TIMP, etc.) following bed rest in old and young subjects.

Primary outcomes

  1. Insulin sensitivity

    Time frame: 10 days

    Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).

Secondary outcomes

  1. Muscle mass

    Time frame: 10 day

    Muscle mass will be measured with bioimpedance and with DXA.

  2. Muscle force

    Time frame: 10 days

    Quadriceps femoris maximal voluntary contractions (MVC) in isometric conditions at knee angle set at 30 deg flexion and hip fixed at 90 deg flexion using a custom-made knee dynamometer fitted with a load cell (RS 206-0290).

  3. Neuromuscular junction stability

    Time frame: 10 days

    We will evaluate the presence of NMJ stability by analysing: AChR subunits expression

Sponsors and collaborators

Lead sponsor

Science and Research Centre Koper

Other

Collaborators

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
  • Izola General Hospital
  • University of Padova
  • University of Pavia
  • University of Trieste
  • University of Udine

Registry information

Official study title

Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.