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RecruitingNCT07430969SPICE IUpdated Jul 2, 2026

The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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:

  • Does electrostimulation improve the balance of muscle protein in ICU patients?
  • Does combining electrostimulation with amino acid help build muscle and prevent muscle loss?

Researchers will compare three groups of patients:

  1. Sham electrostimulation (no current applied) + the standard nutrition
  2. Electrostimulation + the standard nutrition
  3. Electrostimulation + a 20g amino acid bolus

Participants will:

  • Receive either real or sham electrostimulation
  • Get their standard nutrition or a 20g amino acid bolus
  • Have marked amino acids given through an IV
  • Have blood samples taken to measure the amino acids and glucose in the blood
  • Undergo ultrasound of the upper arm to measure the blood flow
Read the detailed description

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:

  1. Sham-NMES + Standard Enteral Nutrition (CON): In this group, participants will receive sham NMES (inactive stimulation) followed by standard nutritional support.
  2. Whole-body NMES + Standard Enteral Nutrition (WB-NMES): This group will receive active whole-body NMES followed by standard nutritional support.
  3. Whole-body NMES + 20g Amino Acid Bolus (WB-NMES+AA): Participants in this group will receive active whole-body NMES followed by a 20g bolus of amino acids.

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.

02

Conditions studied

  • Muscle Wasting in Critically Ill

Keywords

  • NMES
  • Skeletal Muscle Metabolism
  • Protein
  • ICU
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥18 years
  • Expected to need mechanical ventilation for at least 48 hours, judged by physician
  • Expected to reach a Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 (complete sedation), judged by physician
  • Informed consent obtained from the next-of-kin
  • Able to or are receiving gastric tube feeding
  • Have an arterial and a venous line in situ

Exclusion criteria

Exclusion Criteria:

  • Spinal cord injury
  • Previous surgery/local wounds that prohibit whole-body NMES
  • Conditions that prohibit NMES (such open wounds)
  • Chronic neuromuscular disorders (such as Amyotrophic lateral sclerosis (ALS))
  • Acute Kidney Injury (AKI) II and III
  • Undergoing continuous veno-venous hemofiltration (CVVH)
  • Rhabdomyolysis
  • Neuromuscular blocking agents
  • In the caloric restriction period of refeeding syndrome
  • In prone position
  • Burn wounds
  • ICD/pacemaker
  • Pregnant
  • Deemed not suitable to participate based upon the judgement of the treating intensivist
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Sham comparator
    Control group

    Sham-NMES with standard enteral nutrition

    Other: Sham (No Treatment) · Other: Standard enteral nutrition

  • Active comparator
    Whole-body NMES group

    Whole-body NMES stimulation with standard enteral nutrition

    Other: NMES · Other: Standard enteral nutrition

  • Active comparator
    Whole-body NMES + protein group

    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

Interventions

  • OtherSham (No Treatment)

    A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.

  • OtherNMES

    Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.

  • Dietary supplementAmino acid bolus (20g)

    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.

  • OtherStandard enteral nutrition

    The provision of standard nutritional support, typically administered via enteral feeding tubes.

05

What researchers measure

Primary outcomes

  1. Whole-body protein net balance (WPNB)

    WPNB prior to and following NMES (and protein bolus intake)

    Time frame: 7.5 hours

Secondary outcomes

  1. Forearm glucose uptake

    Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake)

    Time frame: 7.5 hours

  2. Forearm amino acid kinetics

    Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion

    Time frame: 7.5 hours

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Hospital Gelderse Vallei
    Ede, Netherlands
    Recruiting
07

Registry details

Key details

Study ID
NCT07430969
Lead sponsor
Wageningen University
Collaborators
Gelderse Vallei Hospital
Responsible party
Marlou Dirks (Associate Professor, Wageningen University) — Principal investigator
First posted
Feb 24, 2026
Start date
Jul 18, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

Marlou Dirks, PhD
Contact
marlou.dirks@wur.nl
+31 317 480 100

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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