NCT06714240 Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU
| NCT ID | NCT06714240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2025-09-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale - Critically ill patients often experience severe skeletal muscle wasting due to an imbalance between muscle protein synthesis (MPS) and degradation, contributing to long-term impairments such as ICU-acquired weakness (ICU-AW) and post-intensive care syndrome (PICS). Effective interventions to mitigate muscle wasting remain a critical unmet need. Protein intake has been identified as a potential modulator of MPS, but anabolic resistance and conflicting evidence regarding optimal protein intake necessitate further investigation. Objective/Hypothesis - This study aims to evaluate the effect of a normal (target: 0.8 g protein/kg/day) versus elevated (target: 1.3 g protein/kg/day) protein intake on MPS rates over four days in critically ill patients. Population - 26 critically ill patients who are suitable for enteral nutrition, mechanically ventilated (min 3 days), and stay at the ICU for at least 7 days will be included. Method: Patients are randomly assigned to two groups (normal or higher protein intake). Muscle biopsies and blood samples will be collected to assess muscle protein synthesis rates.
Eligibility Criteria
Inclusion Criteria: * Aged ≥ 18 years * Suitability for enteral nutrition (i.e., no GI failure, absence of complete intestinal obstruction, no major intra-abdominal sepsis) * Expected mechanical ventilation of minimal three days * Expected ICU stay of at least seven days Exclusion Criteria: * BMI ≥ 40 kg/m² * Spinal cord injury * Chronic corticosteroid use before hospital admission * severe allergies or intolerances (e.g., to cow's milk protein, fish, soy, pea protein or galactosemia) * Severe kidney and/or liver failure * Requirements for dialysis * Bleeding disorders, including anticoagulant and antiplatelet therapy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06714240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06714240 currently recruiting?
Yes, NCT06714240 is actively recruiting participants. Contact the research team at michelle.hendriks@maastrichtuniversity.nl for enrollment information.
Where is the NCT06714240 trial being conducted?
This trial is being conducted at Hasselt, Belgium.
Who is sponsoring the NCT06714240 clinical trial?
NCT06714240 is sponsored by Maastricht University Medical Center. The trial plans to enroll 26 participants.