E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Muscle disuse atrophy |
Spieratrofie |
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E.1.1.1 | Medical condition in easily understood language |
Muscle mass loss |
spiermassa verlies |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the attenuating effect of ND injection and Leu supplementation on muscle mass loss during short-term immobilisation in healthy, young men |
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E.2.2 | Secondary objectives of the trial |
To determine the attenuating effect of ND injection and Leu supplementation on muscle strength loss during short-term immobilisation in healthy, young men.
Elucidate pathways in the muscle that explain the loss of muscle disuse atrophy and the effect of ND and Leu
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male
• Aged from 18-35 years
• 18.5 < BMI < 30 kg/m2
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E.4 | Principal 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)
In case of doubt, in- or exclusion of subject will be discussed with responsible physician or principal investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: quadriceps muscle cross-sectional area (CSA), measured by single-slice CT scan.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 7 days of immobilisation |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 7 days of immobilisation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |