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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376309
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Muscle Atrophy Behavioral: Inactivity Drug: ND Dietary Supplement: Leu Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
Actual Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Leu during inactivity
Leucine supplements
Behavioral: Inactivity
Inactivity

Dietary Supplement: Leu
Leucine supplements
Other Name: Leucine

Experimental: ND during inactivity
Nandrolone injection
Behavioral: Inactivity
Inactivity

Drug: ND
1 nandrolone decanoate injection
Other Name: Nandrolone




Primary Outcome Measures :
  1. CSA Quadriceps (CT scan) [ Time Frame: 7 days ]
    CT scan


Secondary Outcome Measures :
  1. Muscle strength as measured by 1RM test [ Time Frame: 7 days ]
  2. Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376309


Locations
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Netherlands
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Luc van Loon, Prof. Dr. Maastricht University
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02376309    
Other Study ID Numbers: 50679
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nandrolone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents