With this study we want to investigate whether the use of a dietary supplement during immobilization can decrease the loss of muscle mass and strength during immobilization and augment the rate of muscle mass re-gain during recovery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
To assess muscle loss and muscle mass regain during immobilisation and recovery
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effect of protein hydrolysate supplementation on skeletal
muscle mass (quadriceps muscle cross sectional area (CSA)) following 1 week of
leg immobilisation.
Secondary outcome
To determine the effect of protein hydrolysate supplementation on maximal leg
muscle strength (1RM), whole-leg muscle CSA, type I and II muscle fibre size,
muscle protein synthesis rates, and muscle signalling and gene transcription
responses after 1 week of immobilisation and after 2 weeks of recovery.
Background summary
Physical inactivity (which can occur due to for example illness or injury) can
lead to loss of muscle mass. Loss of muscle mass can have negative effects on
for example sports performance, but it can also cause difficulties with daily
activities. A common way to allow a muscle to recover from injury such as a
bone fracture is immobilization (*casting*, which prevents the active use of a
leg). This immobilization often leads to a loss of muscle mass. This loss of
muscle mass can significantly increase the length of recovery. This prolonged
recovery period can have serious negative consequences for some people, such as
for example athletes. To reduce the recovery time it is necessary to develop
strategies that can prevent muscle loss during immobilization. Immobilization
in healthy young subjects is commonly used to investigate such strategies.
Study objective
With this study we want to investigate whether the use of a dietary supplement
during immobilization can decrease the loss of muscle mass and strength during
immobilization and augment the rate of muscle mass re-gain during recovery.
Study design
Parallel group, randomized, double blind.
Intervention
1 week of one-legged immobilisation and 2 weeks of recovery. During the entire
study period, a dietary supplement will be consumed twice daily.
Study burden and risks
You do not have a direct advantage when participating in this research.
However, for the future, this research can yield some relevant information. The
disadvantage of this research is the physical strain: the muscle biopsies and
the blood draws. For the muscle biopsy it is possible that, when the anesthesia
wears off, you can experience some stiffness in your upper leg, similar as a
*knee in the leg* feeling. Furthermore, there is a certain time investment in
this research: The total time investment to visit the University is
approximately 17.5h. Additionally you have to record your dietary intake and
monitor your physical activity in a detailed log for 3 days prior to 3 test
days (9 days in total). Another disadvantage of this research is the diet
restriction: being fasted prior to the test days.
Dawson Street
Dublin 6229 ER
NL
Dawson Street
Dublin 6229 ER
NL
Listed location countries
Age
Inclusion criteria
1) Male
2) Aged 18-35 y
3) BMI 18.5-30.0 kg/m2
Exclusion criteria
(Family) history of thrombosis
Lower limb, back or shoulder injuries (which may interfere with the use of
crutches)
Allergies to milk protein
Participation in structured resistance exercise program
All co-morbidities interacting with mobility and muscle metabolism of the lower
limbs (e.g., arthritis, spasticity/rigidity, all neurological disorders and
paralysis)
Any medications known to (or may) affect protein metabolism (i.e.,
corticosteroids, non-steroidal anti-inflammatories, or prescription strength
acne medications)
Diagnosed metabolic, cardiovascular or intestinal disorders
A history of neuromuscular problems
Use of anti-coagulants
Smoking
(Family) history of Factor V Leiden or other known thrombophilia
Any recent hospital admission/ major surgery
diagnosed diabetes
use of protein and/or fish-oil supplements
participation in a 2H2O study in previous 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68531.068.18 |
| Other | Protocol will be registered at NTR after approval by METC |