An interventional study of Sham (No Treatment) and NMES in Muscle Wasting in Critically Ill, sponsored by Wageningen University. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Wageningen University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to study how whole-body electrical stimulation combined with amino acid intake affects muscle health in ventilated ICU patients. The main questions to answer are:
Researchers will compare three groups of patients:
Participants will:
This clinical trial aims to investigate the effects of whole-body neuromuscular electrical stimulation (NMES) on muscle protein metabolism in mechanically ventilated ICU patients. The study will examine whether NMES, combined with or without amino acid intake, can positively affect muscle protein synthesis and help prevent muscle wasting, which is a common issue in critically ill patients. ICU patients often experience muscle wasting due to prolonged immobility and impaired muscle protein metabolism.
Participants will be randomly assigned to one of three groups:
The main goal of the study is to measure whole-body protein net balance (WPNB), which is the difference between muscle protein synthesis and muscle protein breakdown.
Secondary outcomes include measuring whole-body protein synthesis, protein breakdown, protein oxidation, and muscle glucose uptake, a key indicator of muscle insulin sensitivity.
To assess these outcomes, participants will receive a continuous intravenous infusion of labelled amino acids, and their blood will be sampled at various points. Doppler ultrasound will be used to measure amino acid and glucose balances in the forearm muscles.
This study is crucial for understanding how NMES combined with amino acid intake can improve muscle health and metabolic function in ICU patients, potentially leading to better clinical outcomes, such as reduced muscle wasting and improved recovery during and after an ICU stay.
Wageningen University is the lead sponsor of 153 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sham-NMES with standard enteral nutrition
Other: Sham (No Treatment) · Other: Standard enteral nutrition
Whole-body NMES stimulation with standard enteral nutrition
Other: NMES · Other: Standard enteral nutrition
Whole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition
Other: NMES · Dietary Supplement: Amino acid bolus (20g) · Other: Standard enteral nutrition
A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.
Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.
A bolus dose of 20 grams of amino acids provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism.
The provision of standard nutritional support, typically administered via enteral feeding tubes.
Whole-body protein net balance (WPNB)
WPNB prior to and following NMES (and protein bolus intake)
Time frame: 7.5 hours
Forearm glucose uptake
Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake)
Time frame: 7.5 hours
Forearm amino acid kinetics
Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion
Time frame: 7.5 hours
Splanchnic extraction
The process of removing substances from the blood circulating through the abdominal organs, such as the liver, intestines and spleen. Used to allow correction for splanchnic extraction of enteral amino acids.
Time frame: 9.5 hours
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
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