Muscle Wasting in Critically IllSPICE INCT07430969
The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness
A study testing NMES, Amino acid bolus (20g) and Standard enteral nutrition in people with Muscle Wasting in Critically Ill, run by Wageningen University at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Wasting in Critically Ill
- What is being tested?
- NMES, Amino acid bolus (20g) and Standard enteral nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Single Session of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of an Amino Acid Bolus, on Whole-body Protein Turnover in Sedated Intensive Care Unit (ICU) Patients
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?
Read more
Researchers will compare three groups of patients:
- Sham electrostimulation (no current applied) + the standard nutrition
- Electrostimulation + the standard nutrition
- 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:
- Sham-NMES + Standard Enteral Nutrition (CON): In this group, participants will receive sham NMES (inactive stimulation) followed by standard nutritional support.
- Whole-body NMES + Standard Enteral Nutrition (WB-NMES): This group will receive active whole-body NMES followed by standard nutritional support.
- 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.
- Conditions
- Muscle Wasting in Critically Ill
- Being tested
- Sham (No Treatment), NMES, Amino acid bolus (20g), Standard enteral nutrition
- Keywords
- NMES, Skeletal Muscle Metabolism, Protein, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham (No Treatment)Other
A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.
NMESOther
Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.
Amino acid bolus (20g)Dietary supplement
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.
Standard enteral nutritionOther
The provision of standard nutritional support, typically administered via enteral feeding tubes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Sham-NMES with standard enteral nutrition Receives: Other: Sham (No Treatment); Other: Standard enteral nutrition |
| Whole-body NMES group | Active comparator | Whole-body NMES stimulation with standard enteral nutrition Receives: Other: NMES; Other: Standard enteral nutrition |
| Whole-body NMES + protein group | Active comparator | Whole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition Receives: Other: NMES; Dietary Supplement: Amino acid bolus (20g); Other: Standard enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body protein net balance (WPNB)
WPNB prior to and following NMES (and protein bolus intake)
Measured: 7.5 hours
Secondary outcomes (3)
Forearm glucose uptake
Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake)
Measured: 7.5 hours
Forearm amino acid kinetics
Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion
Measured: 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.
Measured: 9.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Jul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Wasting in Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single test day during which participants will either receive sham- NMES followed by standard enteral nutrition (CON), whole-body NMES stimulation followed by standard enteral nutrition (WB-NMES), or whole-body NMES followed by a bolus of 20g amino acids (WB- NMES+AA). Continuous intravenous infusion of labelled amino acids will be combined with repeated blood samples.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital
- Responsible party
- Principal investigator, Marlou Dirks, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430969
- Sponsor's protocol ID
- NL87298.028.24
- Acronym
- SPICE I
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Session of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of an Amino Acid Bolus, on Whole-body Protein Turnover in Sedated Intensive Care Unit (ICU) Patients
- ClinicalTrials.gov ID
- NCT07430969
- Acronym / sponsor ID
- SPICE I / NL87298.028.24
- Conditions
- Muscle Wasting in Critically Ill
- Keywords
- NMES, Skeletal Muscle Metabolism, Protein, ICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital
- Study start
- 18 Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sham electrostimulation (no current applied) + the standard nutrition
- Electrostimulation + the standard nutrition
- 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
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:
- Sham-NMES + Standard Enteral Nutrition (CON): In this group, participants will receive sham NMES (inactive stimulation) followed by standard nutritional support.
- Whole-body NMES + Standard Enteral Nutrition (WB-NMES): This group will receive active whole-body NMES followed by standard nutritional support.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A single test day during which participants will either receive sham- NMES followed by standard enteral nutrition (CON), whole-body NMES stimulation followed by standard enteral nutrition (WB-NMES), or whole-body NMES followed by a bolus of 20g amino acids (WB- NMES+AA). Continuous intravenous infusion of labelled amino acids will be combined with repeated blood samples.
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Sham (No Treatment), Other: Standard enteral nutritionSham-NMES with standard enteral nutrition |
| Whole-body NMES group | Active comparator | Other: NMES, Other: Standard enteral nutritionWhole-body NMES stimulation with standard enteral nutrition |
| Whole-body NMES + protein group | Active comparator | Other: NMES, Dietary Supplement: Amino acid bolus (20g), Other: Standard enteral nutritionWhole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham (No Treatment)A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES. | Other | Control group |
| NMESActive neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents. | Other | Whole-body NMES + protein group, Whole-body NMES group |
| Amino 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. | Dietary supplement | Whole-body NMES + protein group |
| Standard enteral nutritionThe provision of standard nutritional support, typically administered via enteral feeding tubes. | Other | Control group, Whole-body NMES + protein group, Whole-body NMES group |
Primary outcome
Whole-body protein net balance (WPNB)
Time frame: 7.5 hours
WPNB prior to and following NMES (and protein bolus intake)
3 secondary outcomes
Forearm glucose uptake
Time frame: 7.5 hours
Forearm amino acid kinetics
Time frame: 7.5 hours
Splanchnic extraction
Time frame: 9.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES, Amino acid bolus (20g) and Standard enteral nutrition in people with Muscle Wasting in Critically Ill, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlou Dirks, PhD (+31 317 480 100, marlou.dirks@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body protein net balance (WPNB) (time frame: 7.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.