The primary aim of this study is to determine the effect of nandrolone decanoate (ND) injection and leucine supplementation on muscle mass loss during short-term immobilisation in healthy, young people. In addition, we aim to study the underlying…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quadriceps CSA
Secondary outcome
whole upper leg muscle CSA
muscle fiber type specific CSA
muscle fiber type-specific satellite cell content
1RM muscle strength
Background summary
Muscle loss can occur for several reasons, such as inactivity because of
illness or injury, illnesses themselves or simply old age. 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. One way
to induce muscle loss and study its effects is immobilisation. Previous studies
have shown that immobilisation of the knee can rapidly induce muscle atrophy.
To reduce rehabilitation time following immobilization intervention strategies
need to be developed to reduce the loss of muscle during immobilisation.
Several nutrients have shown promise regarding the protection of muscle mass in
catabolic situations, two of which are nandrolone decanoate (ND) and leucine.
With this study we investigate whether ingesting leucine or getting a ND
injection during immobilization will reduce the loss of muscle mass and
strength during a 7 days sinlge leg immobilisation period.
Study objective
The primary aim of this study is to determine the effect of nandrolone
decanoate (ND) injection and leucine supplementation on muscle mass loss during
short-term immobilisation in healthy, young people. In addition, we aim to
study the underlying mechanisms of ND and leucine and disuse muscular atrophy.
Study design
The present study will use a randomised, placebo-controlled parallel-arm study
design with two groups. All volunteers (n=30) will be subjected to 7 days of
one legged knee immobilisation by means of a full leg cast, either with
nandrolone decanoate (n=15, ND group) or leucine (n=15, leucine group). The
placebo group from a parallel study (METC 13-3-023) will be used as a control
group.
Intervention
One leg will be immobilized at a 30 degree knee joint angle of flexion for 7
days by means of a full leg cast.
In addition, participants will ad random be allocated to the leucine group or
nandrolone decanoate group. Participants in the leucine group get 3x2.5 grams
of leucine (every meal) for 1 week (during immobilisation). Participants in the
ND group will get 200 mg nandrolone decanoaat at the start of the
immobilisation period.
Study burden and risks
The risks involved in participating in this experiment are minimal.
The incision made for obtaining the muscle biopsy will be performed by an
experienced physician and will heal completely. Within our research group we
have extensive experience with taking muscle biopsies. During the blood draw
there is a small risk of fainting or hematoma. These risks are minimized by
using trained and experienced personnel for taking the blood draw and always
applying adequate pressure following the blood draw.
The Aviko vacuum-packed and pre-weighed meals are normal food products and have
been cleared for human consumption. There are no complications associated with
the procedure of a single slice lower limb CT scan.
The immobilization period will lead to loss of muscle mass and strength in the
immobilized leg. However, previous studies have shown that this loss in muscle
mass and strength returns to pre-immobilized values within weeks after cast
removal, without specific training.
Side effects of nandrolone supplementation have been reported, depending on
dose and sensitivity: increase libido, hair loss, acne, rash, itch, nausea,
muscle soreness, malaise, oedema, increased blood pressure, decreased liver
function, bruise or swelling at the injection place, hoarseness, increased
prostate or penis, longer and/or sometimes painful erections and disturbance in
forming of sperm cells.
No side effects have been reported for leucine.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Male
Aged from 18-35 years
18.5 < BMI < 30 kg/m2
Exclusion criteria
(Family) history of thromboembolic events
Smoking
Recent surgery < 6 months
Performing regular resistance training more than once 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, growth hormone, testosterone, immunosuppressants or insulin
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
Use of insulin or blood sugar decreasing medication or EPO
Migraine
Allergy to nuts or soy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-000578-37-NL |
ClinicalTrials.gov | NCT02376309 |
CCMO | NL50679.068.15 |
OMON | NL-OMON29489 |