The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

NCT ID: NCT02376309

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Leu during inactivity

Leucine supplements

Group Type EXPERIMENTAL

Inactivity

Intervention Type BEHAVIORAL

Inactivity

Leu

Intervention Type DIETARY_SUPPLEMENT

Leucine supplements

ND during inactivity

Nandrolone injection

Group Type EXPERIMENTAL

Inactivity

Intervention Type BEHAVIORAL

Inactivity

ND

Intervention Type DRUG

1 nandrolone decanoate injection

Interventions

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Inactivity

Inactivity

Intervention Type BEHAVIORAL

ND

1 nandrolone decanoate injection

Intervention Type DRUG

Leu

Leucine supplements

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nandrolone Leucine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc van Loon, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University Medical Centre+

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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50679

Identifier Type: -

Identifier Source: org_study_id

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