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

NCT07430969 | Recruiting

• 1 other identifier: NL87298.028.24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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:
• Sham electrostimulation (no current applied) + the standard nutrition
• Electrostimulation + the standard nutrition
• Electrostimulation + a 20g amino acid bolus
• 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

Conditions

Muscle Wasting in Critically Ill

Keywords

NMES; Skeletal Muscle Metabolism; Protein; ICU

Outcome Measures

Primary Outcomes (1)

• Whole-body protein net balance (WPNB)

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

  7.5 hours

Secondary Outcomes (3)

• Forearm glucose uptake

  7.5 hours

• Forearm amino acid kinetics

  7.5 hours

• Splanchnic extraction

  9.5 hours

Study Arms (3)

Control group

SHAM COMPARATOR

Sham-NMES with standard enteral nutrition

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

Whole-body NMES group

ACTIVE COMPARATOR

Whole-body NMES stimulation with standard enteral nutrition

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

Other: NMES; Dietary Supplement: Amino acid bolus (20g); Other: Standard enteral nutrition

Interventions

Sham (No Treatment) OTHER

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

Control group

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.

Whole-body NMES + protein group

Standard enteral nutrition OTHER

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

Control group; Whole-body NMES + protein group; Whole-body NMES group

NMES OTHER

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

Whole-body NMES + protein group; Whole-body NMES group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Gelderse Vallei Hospital: collaborator

Study Sites (1)

Hospital Gelderse Vallei

Ede, Netherlands

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Marlou Dirks, PhD

CONTACT

+31 317 480 100; marlou.dirks@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

NL (1)