Bed Rest Study SBI 2023

NCT06141291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-11-21

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Aging
  • Physical Inactivity

Interventions

DIETARY_SUPPLEMENT

High protein diet

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.

DIAGNOSTIC_TEST

OGTT

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.

Sponsors & Collaborators

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

    collaborator UNKNOWN
  • Izola General Hospital

    collaborator OTHER
  • University of Padova

    collaborator OTHER
  • University of Udine

    collaborator OTHER
  • University of Pavia

    collaborator OTHER
  • University of Trieste

    collaborator OTHER
  • Science and Research Centre Koper

    lead OTHER

Principal Investigators

  • Rado Pišot, PhD · Science and Research Centre Koper

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2023-10-22
Completion
2023-10-22

Countries

  • Slovenia

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 NCT06141291 on ClinicalTrials.gov