|- candidate number||14727|
|- NTR Number||NTR3952|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-apr-2013|
|- Secondary IDs||44582 / 13-3-024; ABR / METC MUMC|
|- Public Title||Nocturnal muscle protein synthesis after neuromuscular electrical stimulation in elderly men.|
|- Scientific Title||Nocturnal muscle protein synthesis after neuromuscular electrical stimulation in elderly men.|
|- hypothesis||Is overnight incorporation of [1-13C]-phenylalanine amino acids higher in muscle tissue in combination with NMES than in unstimulated skeletal muscle?|
|- Healt Condition(s) or Problem(s) studied||Sarcopenia, Muscle mass, Protein, Neuromuscular electrostimulation|
|- Inclusion criteria||1. Written informed consent;|
2. Age ≥ 65 years;
|- Exclusion criteria||1. Type II diabetes;|
2. All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery);
3. Use of anticoagulants, blood diseases, allergy for lidocain;
4. Use of NSAIDs and acetylsalicylic acid;
5. Patients suffering from PKU (Phenylketonuria);
6. Presence of implantable cardioverter defibrillator and/or pacemaker;
7. Performed regular resistance type exercise in the past 6 months;
8. Use of any tools to assist during walking (cane/ crutches/ walker);
9. (Partial) foot/ leg amputation.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-jan-2014|
|- Target number of participants||12|
|- Interventions||Consumption of a 40 g bolus of intrinsically L[1-13C]-phenylalanine labeled casein protein and 70 min of one-legged NMES.|
|- Primary outcome||Primary parameter of this study will be overnight incorporation of stable isotope amino acids from the intrinsically labeled drink. |
|- Secondary outcome||Secondary parameter of this study will be plasma amino acid enrichment after ingestion of the intrinsically labeled protein.|
|- Timepoints||Overnight (i.e. the morning after ingestion of the stable isotope drink and NMES). Method of measurement is massaspectrometry. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Ba. B. Groen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. L.J.C. Loon, van|
|- Sponsor/Initiator ||University Maastricht (UM), Department Movement Science |
(Source(s) of Monetary or Material Support)
|University Maastricht (UM)|
|- Brief summary||Rationale:|
With human aging there is a gradual but progressive decline in skeletal muscle mass, termed sarcopenia. While the underlying cause of sarcopenia is likely to be multifaceted, a primary factor is that elderly individuals frequently experience short periods of muscle disuse following limb immobilization or bed-rest (due to injury or illness) causing rapid muscle loss. Feasible strategies for maintaining muscle protein synthesis rates in elderly individuals, and thus having the potential to attenuate the loss of muscle mass during disuse need to be pursued. Local neuromuscular electrical stimulation (NMES) in combination with additional intake of protein offer such a potential strategy but, as yet, remains relatively unexplored.
To test the hypothesis that ingesting a nocturnal bolus of protein in combination with NMES stimulates muscle protein synthesis in elderly more than ingesting protein without NMES.
Prospective, single blind, intervention study.
Consumption of a 40 g bolus of intrinsically L[1-13C]-phenylalanine labeled casein protein and 70 min of one-legged NMES.
Enrichments of muscle tissue after ingestion of an [1-13C]-phenylalanine intrinsically labeled casein drink.
|- Main changes (audit trail)|
|- RECORD||15-apr-2013 - 2-sep-2013|