Bed Rest Study SBI 2023
NCT06141291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2023-11-21
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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