Overview

This trial is active, not recruiting.

Condition muscle atrophy
Treatments inactivity, nd, leu
Sponsor Maastricht University Medical Center
Start date August 2015
End date June 2016
Trial size 30 participants
Trial identifier NCT02376309, 50679

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Leucine supplements
inactivity
Inactivity
leu Leucine
Leucine supplements
(Experimental)
Nandrolone injection
inactivity
Inactivity
nd Nandrolone
1 nandrolone decanoate injection

Primary Outcomes

Measure
CSA Quadriceps (CT scan)
time frame: 7 days

Secondary Outcomes

Measure
Muscle strength as measured by 1RM test
time frame: 7 days
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
time frame: 7 days

Eligibility Criteria

Male participants from 18 years up to 35 years old.

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.

Additional Information

Official title The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
Principal investigator Luc van Loon, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.