The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

Not Applicable

Completed

• Conditions: Muscle Atrophy
• Interventions: Behavioral: Inactivity; Drug: ND; Dietary Supplement: Leu

• Registration Number: NCT02376309
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Study Start: 2015-08
• Primary Completion: 2016-08
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ND during inactivity	Inactivity	Nandrolone injection
ND during inactivity	ND	Nandrolone injection
Leu during inactivity	Inactivity	Leucine supplements
Leu during inactivity	Leu	Leucine supplements

Primary Outcome Measures

Name	Time	Method
CSA Quadriceps (CT scan)	7 days	CT scan

Secondary Outcome Measures

Name	Time	Method
Muscle strength as measured by 1RM test	7 days
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy	7 days

Trial Locations

Locations (1)

Maastricht University Medical Centre+; 🇳🇱 Maastricht, Limburg, Netherlands