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OpenTrials
Completed

NCT Number: NCT02376309

The Effect of Nandrolone Decanoate and Leucine 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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inactivity

Behavioral

Inactivity

ND

Drug

1 nandrolone decanoate injection

Other names: Nandrolone

Leu

Dietary Supplement

Leucine supplements

Other names: Leucine

Primary outcomes

  1. CSA Quadriceps (CT scan)

    Time frame: 7 days

    CT scan

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss

Acronym: Le-Na

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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