Healthy AgingNCT06141291
Bed Rest Study SBI 2023
A study testing High protein diet and OGTT in people with Healthy Aging and Physical Inactivity, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Physical Inactivity
- What is being tested?
- High protein diet and OGTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSlovenia
- Study dates
- 21 Aug 2023to 22 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: for young arm (18-35), for old arm (65-75)
- BMI: 22 in 32 kg/m2
- appendicular muscle mass > 7,23 kg/m2
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults
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
- Being tested
- High protein diet, OGTT
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietDietary 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.
OGTTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).
Measured: 10 days
Secondary outcomes (3)
Muscle mass
Muscle mass will be measured with bioimpedance and with DXA.
Measured: 10 day
Muscle force
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).
Measured: 10 days
Neuromuscular junction stability
We will evaluate the presence of NMJ stability by analysing: AChR subunits expression
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start21 Aug 2023
- Primary completion22 Oct 2023
- Study completion22 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Izola General Hospital, University of Padova, University of Udine, University of Pavia, University of Trieste
- Responsible party
- Principal investigator, Rado Pisot, Science and Research Centre Koper
- Investigators
- Rado Pišot, PhD, Principal investigator, Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141291
- Sponsor's protocol ID
- BEDREST
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Decline After Physical Inactivity: a Comparison of Younger and Older Adults
- ClinicalTrials.gov ID
- NCT06141291
- Acronym / sponsor ID
- BEDREST
- Conditions
- Healthy Aging, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Izola General Hospital, University of Padova, University of Udine, University of Pavia, University of Trieste
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Old 1 | Other | Diagnostic Test: OGTT1. 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 | Experimental | Dietary Supplement: High protein diet, Diagnostic Test: OGTT1. 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. |
| Young | Other | Diagnostic Test: OGTT1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: for young arm (18-35), for old arm (65-75)
- BMI: 22 in 32 kg/m2
- appendicular muscle mass > 7,23 kg/m2
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein dietTest 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 | Old 2 |
| OGTTAssessment 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 | Old 1, Old 2, Young |
Primary outcome
Insulin sensitivity
Time frame: 10 days
Assessment in changes in insulin sensitivity will be made with the use of Oral Glucose Tolerance test (OGTT).
3 secondary outcomes
Muscle mass
Time frame: 10 day
Muscle force
Time frame: 10 days
Neuromuscular junction stability
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rado Pišot, PhD principal investigator
Science and Research Centre Koper
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet and OGTT in people with Healthy Aging and Physical Inactivity, run by Science and Research Centre Koper at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.