Bed Rest Study SBI 2023

NCT ID: NCT06141291

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2023-10-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Old 1

1\. 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.

Group Type: OTHER

OGTT

Intervention Type: 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.

Old 2

1. 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.

2. 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.

Group Type: EXPERIMENTAL

High protein diet

Intervention Type: 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

Intervention Type: 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.

Young

1\. 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.

Group Type: OTHER

OGTT

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

UNKNOWN

Sponsor Role: collaborator

Izola General Hospital

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

University of Udine

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: collaborator

University of Trieste

OTHER

Sponsor Role: collaborator

Science and Research Centre Koper

OTHER

Sponsor Role: lead

Responsible Party

Rado Pisot

Director, Scientific councillor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rado Pišot, PhD

Role: PRINCIPAL_INVESTIGATOR

Science and Research Centre Koper

Locations

SRC Koper

Koper, , Slovenia

Countries

Slovenia

Other Identifiers

BEDREST

Identifier Type: -

Identifier Source: org_study_id