Back to resultsThe Effect of Nandrolone Decanoate and Leucine on Muscle Loss (Le-Na)
Primary Purpose
Muscle Atrophy
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Inactivity
ND
Leu
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Atrophy
Eligibility 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.
Sites / Locations
- Maastricht University Medical Centre+
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Leu during inactivity
ND during inactivity
Arm Description
Leucine supplements
Nandrolone injection
Outcomes
Primary Outcome Measures
CSA Quadriceps (CT scan)
CT scan
Secondary Outcome Measures
Muscle strength as measured by 1RM test
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
Full Information
NCT ID
NCT02376309
First Posted
February 19, 2015
Last Updated
August 28, 2017
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02376309
Brief Title
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss
Acronym
Le-Na
Official Title
The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leu during inactivity
Arm Type
Experimental
Arm Description
Leucine supplements
Arm Title
ND during inactivity
Arm Type
Experimental
Arm Description
Nandrolone injection
Intervention Type
Behavioral
Intervention Name(s)
Inactivity
Intervention Description
Inactivity
Intervention Type
Drug
Intervention Name(s)
ND
Other Intervention Name(s)
Nandrolone
Intervention Description
1 nandrolone decanoate injection
Intervention Type
Dietary Supplement
Intervention Name(s)
Leu
Other Intervention Name(s)
Leucine
Intervention Description
Leucine supplements
Primary Outcome Measure Information:
Title
CSA Quadriceps (CT scan)
Description
CT scan
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Muscle strength as measured by 1RM test
Time Frame
7 days
Title
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
Time Frame
7 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, Prof. Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200MD
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss
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