Bed Rest Study SBI 2023

NCT06141291 | Completed DMC

• 1 other identifier: BEDREST
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

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

  10 days

Secondary Outcomes (3)

• Muscle mass

  10 day

• Muscle force

  10 days

• Neuromuscular junction stability

  10 days

Study Arms (3)

Old 1

OTHER

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.

Diagnostic Test: OGTT

Old 2

EXPERIMENTAL

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.

Dietary Supplement: High protein diet; Diagnostic Test: OGTT

Young

OTHER

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.

Diagnostic Test: OGTT

Interventions

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.

Old 2

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.

Old 1; Old 2; Young

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Science and Research Centre Koper: lead
• Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI): collaborator
• Izola General Hospital: collaborator
• University of Padova: collaborator
• University of Udine: collaborator
• University of Pavia: collaborator
• University of Trieste: collaborator

Study Sites (1)

SRC Koper

Koper, 6000, Slovenia

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Diet, High-Protein; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Rado Pišot, PhD

  Science and Research Centre Koper

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scientific councillor

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 21, 2023
• Study Start: August 21, 2023
• Primary Completion: October 22, 2023
• Study Completion: October 22, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)