About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Nutritionally complete Tube Feed with standard protein levels
- Nutritionally complete Tube Feed with higher protein levels
Treatment groups
Sponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Danone Global Research & Innovation Center
Collaborator