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

August 28, 2017 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200MD
        • Maastricht University Medical Centre+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leu during inactivity
Leucine supplements
Behavioral: Inactivity
Inactivity
Dietary supplement: Leu
Leucine supplements
Other Names:
  • Leucine
Experimental: ND during inactivity
Nandrolone injection
Behavioral: Inactivity
Inactivity
Drug: ND
1 nandrolone decanoate injection
Other Names:
  • Nandrolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSA Quadriceps (CT scan)
Time Frame: 7 days
CT scan
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle strength as measured by 1RM test
Time Frame: 7 days
7 days
Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Luc van Loon, Prof. Dr., Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50679

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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