Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:42 PM
Study NCT ID:
NCT07430969
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body protein net balance (WPNB)', 'timeFrame': '7.5 hours', 'description': 'WPNB prior to and following NMES (and protein bolus intake)'}], 'secondaryOutcomes': [{'measure': 'Forearm glucose uptake', 'timeFrame': '7.5 hours', 'description': 'Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake)'}, {'measure': 'Forearm amino acid kinetics', 'timeFrame': '7.5 hours', 'description': 'Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion'}, {'measure': 'Splanchnic extraction', 'timeFrame': '9.5 hours', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NMES', 'Skeletal Muscle Metabolism', 'Protein', 'ICU'], 'conditions': ['Muscle Wasting in Critically Ill']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does electrostimulation improve the balance of muscle protein in ICU patients?\n* Does combining electrostimulation with amino acid help build muscle and prevent muscle loss?\n\nResearchers will compare three groups of patients:\n\n1. Sham electrostimulation (no current applied) + the standard nutrition\n2. Electrostimulation + the standard nutrition\n3. Electrostimulation + a 20g amino acid bolus\n\nParticipants will:\n\n* Receive either real or sham electrostimulation\n* Get their standard nutrition or a 20g amino acid bolus\n* Have marked amino acids given through an IV\n* Have blood samples taken to measure the amino acids and glucose in the blood\n* Undergo ultrasound of the upper arm to measure the blood flow', 'detailedDescription': '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.\n\nParticipants will be randomly assigned to one of three groups:\n\n1. Sham-NMES + Standard Enteral Nutrition (CON): In this group, participants will receive sham NMES (inactive stimulation) followed by standard nutritional support.\n2. Whole-body NMES + Standard Enteral Nutrition (WB-NMES): This group will receive active whole-body NMES followed by standard nutritional support.\n3. 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.\n\nThe 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.\n\nSecondary outcomes include measuring whole-body protein synthesis, protein breakdown, protein oxidation, and muscle glucose uptake, a key indicator of muscle insulin sensitivity.\n\nTo 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years\n* Expected to need mechanical ventilation for at least 48 hours, judged by physician\n* Expected to reach a Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 (complete sedation), judged by physician\n* Informed consent obtained from the next-of-kin\n* Able to or are receiving gastric tube feeding\n* Have an arterial and a venous line in situ\n\nExclusion Criteria:\n\n* Spinal cord injury\n* Previous surgery/local wounds that prohibit whole-body NMES\n* Conditions that prohibit NMES (such open wounds)\n* Chronic neuromuscular disorders (such as Amyotrophic lateral sclerosis (ALS))\n* Acute Kidney Injury (AKI) II and III\n* Undergoing continuous veno-venous hemofiltration (CVVH)\n* Rhabdomyolysis\n* Neuromuscular blocking agents\n* In the caloric restriction period of refeeding syndrome\n* In prone position\n* Burn wounds\n* ICD/pacemaker\n* Pregnant\n* Deemed not suitable to participate based upon the judgement of the treating intensivist'}, 'identificationModule': {'nctId': 'NCT07430969', 'acronym': 'SPICE I', 'briefTitle': 'The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NL87298.028.24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Sham-NMES with standard enteral nutrition', 'interventionNames': ['Other: Sham (No Treatment)', 'Other: Standard enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole-body NMES group', 'description': 'Whole-body NMES stimulation with standard enteral nutrition', 'interventionNames': ['Other: NMES', 'Other: Standard enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole-body NMES + protein group', 'description': 'Whole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition', 'interventionNames': ['Other: NMES', 'Dietary Supplement: Amino acid bolus (20g)', 'Other: Standard enteral nutrition']}], 'interventions': [{'name': 'Sham (No Treatment)', 'type': 'OTHER', 'description': 'A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.', 'armGroupLabels': ['Control group']}, {'name': 'NMES', 'type': 'OTHER', 'description': 'Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.', 'armGroupLabels': ['Whole-body NMES + protein group', 'Whole-body NMES group']}, {'name': 'Amino acid bolus (20g)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Whole-body NMES + protein group']}, {'name': 'Standard enteral nutrition', 'type': 'OTHER', 'description': 'The provision of standard nutritional support, typically administered via enteral feeding tubes.', 'armGroupLabels': ['Control group', 'Whole-body NMES + protein group', 'Whole-body NMES group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ede', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Hospital Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}], 'centralContacts': [{'name': 'Marlou Dirks, PhD', 'role': 'CONTACT', 'email': 'marlou.dirks@wur.nl', 'phone': '+31 317 480 100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gelderse Vallei Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marlou Dirks', 'investigatorAffiliation': 'Wageningen University'}}}}