Muscle AtrophyLe-NaNCT02376309
The Effect of Nandrolone Decanoate and Leucine on Muscle Loss
A study testing Inactivity, ND and Leu in people with Muscle Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- Inactivity, ND and Leu
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men 18-35 years
- BMI between 18.5 and 30 kg/m2
Who cannot join
- (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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6200MD
About this study
Official title: The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
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.
- Conditions
- Muscle Atrophy
- Being tested
- Inactivity, ND, Leu
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InactivityBehavioural
Inactivity
NDDrug
Also called Nandrolone
1 nandrolone decanoate injection
LeuDietary supplement
Also called Leucine
Leucine supplements
| Study group | Role | What they receive |
|---|---|---|
| Leu during inactivity | Experimental | Leucine supplements Receives: Behavioral: Inactivity; Dietary Supplement: Leu |
| ND during inactivity | Experimental | Nandrolone injection Receives: Behavioral: Inactivity; Drug: ND |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA Quadriceps (CT scan)
CT scan
Measured: 7 days
Secondary outcomes (2)
Muscle strength as measured by 1RM test
Measured: 7 days
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376309
- Sponsor's protocol ID
- 50679
- Acronym
- Le-Na
- Status last verified
- Aug 2017
- First submitted
- 19 Feb 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
- ClinicalTrials.gov ID
- NCT02376309
- Acronym / sponsor ID
- Le-Na / 50679
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leu during inactivity | Experimental | Behavioral: Inactivity, Dietary Supplement: LeuLeucine supplements |
| ND during inactivity | Experimental | Behavioral: Inactivity, Drug: NDNandrolone injection |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men 18-35 years
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (14 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InactivityInactivity | Behavioural | Leu during inactivity, ND during inactivity |
| NDAlso: Nandrolone1 nandrolone decanoate injection | Drug | ND during inactivity |
| LeuAlso: LeucineLeucine supplements | Dietary supplement | Leu during inactivity |
Primary outcome
CSA Quadriceps (CT scan)
Time frame: 7 days
CT scan
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivity, ND and Leu in people with Muscle Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA Quadriceps (CT scan) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.