To investigate the effect of multiple sessions of whole body NMES, with or without consecutive protein intake, on muscle protein synthesis.
ID
Source
Brief title
Condition
- Protein and amino acid metabolism disorders NEC
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Myofibrillar fractional synthetic rate (muscle protein synthesis).
Secondary outcome
• Quadriceps muscle layer thickness (measured via ultrasound)
• Body composition (measured by dual-energy X-ray absorptiometry; DXA)
• Quadriceps muscle strength and function (measured via the Humac Norm
Dynamometer)
• Handgrip strength
• 24h nitrogen balance (measured via dietary intake and urinary nitrogen
excretion)
Background summary
Patients admitted to the hospital often undergo a period of bed rest. This
state of whole-body disuse quickly leads to patients experiencing a substantial
loss of muscle mass and strength. In the intensive care unit (ICU), this is
accompanied by muscle wasting (i.e. the loss of muscle proteins) and
ICU-acquired weakness (ICU-AW), which lead to an increased time of mechanical
ventilation, morbidity, negative post-ICU consequences and an overall decreased
quality of life (QoL). The building blocks of our muscles, called amino acids,
are primarily acquired through dietary intake. A fundamental cause for
ICU-induced muscle wasting is an impaired response to the anabolic properties
of dietary protein. Neuromuscular electrical stimulation (NMES) could stimulate
muscle amino acid metabolism and alleviate some of these negative consequences
by reintroducing (involuntary) muscle contractions via small electric currents.
Previous research has shown that NMES of the quadriceps muscle alleviated
muscle wasting in sedated patients. In this study, we will mimic
hospitalization via bed rest, to get to the root of the on-set of muscle
wasting during muscle disuse, and to test on both a molecular and functional
level, what the effects are of acute and multiple sessions of whole-body NMES
in combination with timed protein intake on muscle protein metabolism.
Study objective
To investigate the effect of multiple sessions of whole body NMES, with or
without consecutive protein intake, on muscle protein synthesis.
Study design
Randomised, placebo-controlled design with three parallel groups
Intervention
3-day bed rest study in which participants receive sham NMES followed by a 20g
glucose drink (CON), whole body NMES stimulation followed by a 20g glucose
drink (WB-NMES), or whole body NMES followed by a 20g protein drink
(WB-NMES+PRO). Heavy water will be administered to determine the enrichment in
the muscles (m. vastus lateralis) and determine the muscle protein synthesis
rates.
Study burden and risks
Insertion of the catheters in a vein is comparable to a routine blood draw, and
the only risk is a small local hematoma. NMES has been applied by ourselves and
others to healthy participants and critically ill patients, and has been proven
to be safe when applied by trained staff. The amount of heavy water is
distributed under sterile conditions according to GMP standards for each
loading or top-up moment. It is also routinely used in human skeletal muscle
metabolism research. Bleeding and infections are possible after a muscle
biopsy, but are rare with proper aftercare; the test subjects receive extensive
oral and written information about this. It has been shown that a few weeks
after bed rest, muscle mass, strength and function return to completely normal.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
• Aged from 18-35 years
• 18.5 < BMI < 30 kg·m2
• Recreationally active (performing non-competitive physical exercise at least
one time per week for minimally 30 minutes)
• Informed consent obtained
Exclusion criteria
• Employed or undertaking a thesis or internship at the department of Human and
Animal Physiology at Wageningen University
• Smoking
• Diabetes (Type 1, Type 2, or genetic form of diabetes)
• Any diagnosed cardiovascular (heart) disease or high blood pressure (>=140
mmHg systolic and/or >=90 mmHg diastolic)
• Chronic use of any prescribed or over the counter pharmaceuticals (excluding
oral contraceptives and contraceptive devices)
• Known allergy to lidocaine
• Prone to keloid forming (i.e. hyperplastic growth of scars)
• All co-morbidities interacting with mobility and muscle metabolism of the
lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders
and paralysis)
• Regular use of dietary protein and/or amino acid supplements (>3 times per
week)
• Currently involved in a structured progressive resistance training programme
(>3 times per week)
• A personal or family history of thrombosis (clots), epilepsy, seizures, or
schizophrenia
• Any previous motor disorders or disorders in muscle and/or lipid metabolism
• Any back, leg, knee, neck, shoulder or postural complaints
• Presence of an ulcer in the stomach or gut and/or strong history of
indigestion
• Contra-indications for DXA scans (e.g. undergoing radiologic examination)
• Lactose intolerance
• Known severe kidney problems
• Pregnant or breastfeeding
• Unable to give consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL88628.028.24 |