Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

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

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Danone Global Research & Innovation Center

Collaborator