The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

Muscle Atrophy Clinical Trial

— Le-Na  

Official title:

The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376309
• Other study ID #: 50679
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: August 28, 2017
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy
• Muscular Atrophy

Intervention

Behavioral:
• Inactivity
Inactivity

Drug:
• ND
1 nandrolone decanoate injection

Dietary Supplement:
• Leu
Leucine supplements

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSA Quadriceps (CT scan)	CT scan	7 days
Secondary	Muscle strength as measured by 1RM test		7 days
Secondary	Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy		7 days