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The effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss During Immobilisation


- candidate number22408
- NTR NumberNTR5290
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2015
- Secondary IDsNL50679.068.15 CCMO
- Public TitleThe effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss During Immobilisation
- Scientific TitleThe effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss During Immobilisation
- ACRONYMLeNa
- hypothesis1. Nandrolone decanoate injection reduces muscle loss in the upper leg during immobilisation
2. Leucine supplementation during immobilisation of the knee reduces muscle loss in the upper leg
- Healt Condition(s) or Problem(s) studiedMuscle atrofy
- Inclusion criteriaMale
Aged from 18-35 years
18.5 < BMI < 30 kg/m2
- Exclusion criteria (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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2015
- planned closingdate1-mrt-2018
- Target number of participants30
- InterventionsImmobilisation with nandrolone decanoate OR
Immobilisation with leucine supplements
- Primary outcomeQuadriceps cross sectional area
- Secondary outcomeWhole thigh muscle CSA; muscle fibre type-specific CSA and muscle fibre type-specific satellite cell content, muscle strength.
- TimepointsTests at baseline and after immobilisation
- Trial web sitena
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Evelien Backx
- CONTACT for SCIENTIFIC QUERIES Evelien Backx
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- Publicationsna
- Brief summary
- Main changes (audit trail)
- RECORD2-jul-2015 - 8-aug-2016


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