The Effect of Nandrolone Decanoate and Leucine on Muscle Loss (Le-Na)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Muscle Atrophy

Treatments: Behavioral: Inactivity; Drug: ND; Dietary Supplement: Leu

Study type: Interventional

Funder types: Other

Identifiers

NCT02376309

50679

Details and patient eligibility

About

A decrease in muscle mass can have a profound impact on quality of life, as it can lead to decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this study we investigate whether ingesting leucine or getting a ND injection will reduce the loss of muscle mass and strength.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men 18-35 years
• BMI between 18.5 and 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) In case of doubt, in- or exclusion of subject will be discussed with responsible physician or principal investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Leu during inactivity

Experimental group

Description:

Leucine supplements

Treatment:

Behavioral: Inactivity

Dietary Supplement: Leu

ND during inactivity

Experimental group

Description:

Nandrolone injection

Treatment:

Behavioral: Inactivity

Drug: ND