The Effect of Nandrolone Decanoate and Leucine on Muscle Loss

NCT02376309 | Completed DMC

• 1 other identifier: 50679
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• CSA Quadriceps (CT scan)

  CT scan

  7 days

Secondary Outcomes (2)

• Muscle strength as measured by 1RM test

  7 days

• Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy

  7 days

Study Arms (2)

Leu during inactivity

EXPERIMENTAL

Leucine supplements

Behavioral: Inactivity; Dietary Supplement: Leu

ND during inactivity

EXPERIMENTAL

Nandrolone injection

Behavioral: Inactivity; Drug: ND

Interventions

Inactivity BEHAVIORAL

Inactivity

Leu during inactivity; ND during inactivity

ND DRUG

1 nandrolone decanoate injection

Also known as: Nandrolone

ND during inactivity

Leu DIETARY_SUPPLEMENT

Leucine supplements

Also known as: Leucine

Leu during inactivity

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men 18-35 years
• BMI between 18.5 and 30 kg/m2

You may not qualify if:

• \- (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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Nandrolone; Leucine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Luc van Loon, Prof. Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 3, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

NL (1)