The effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss During inactivity
- Conditions
- Muscle disuse atrophyTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-000578-37-NL
- Lead Sponsor
- Maastricht University Medical Centre+
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
•Male
•Aged from 18-35 years
•18.5 < BMI < 30 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• (Family) history of thromboembolic events
•Smoking
•Recent surgery (within 6 months prior to the study)
•Performing progressive resistance training more than three times per week in the past year
•Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
•Current systemic use of corticosteroids, anabolic steroids, growth hormone, testosterone, nandrolone, protein supplements, immunosuppressants or insulin, blood sugar decreasing medication or EPO
•All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
•Use of anti-coagulants
•Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)
•Liver disease
•Heart failure
•Migraine
•Allergy to nuts or soy
•High blood pressure (>140 mmHg systolic and >90 mmHg diastolic)
In case of doubt, in- or exclusion of subject will be discussed with responsible physician or principal investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the attenuating effect of ND injection and Leu supplementation on muscle mass loss during short-term immobilisation in healthy, young men;Secondary Objective: To determine the attenuating effect of ND injection and Leu supplementation on muscle strength loss during short-term immobilisation in healthy, young men.<br>Elucidate pathways in the muscle that explain the loss of muscle disuse atrophy and the effect of ND and Leu <br>;Primary end point(s): Primary: quadriceps muscle cross-sectional area (CSA), measured by single-slice CT scan. <br>;Timepoint(s) of evaluation of this end point: After 7 days of immobilisation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary: Leg muscle strength (1-RM), type I and II muscle fiber size and satellite cell content, whole thigh muscle CSA and expression and phosphorylation status of proteins and myogenic regulatory factors.<br>;Timepoint(s) of evaluation of this end point: After 7 days of immobilisation