RecruitingNot ApplicableNCT06714240

Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients


Sponsor

Maastricht University Medical Center

Enrollment

26 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DIETARY_SUPPLEMENTNutritionally complete Tube Feed with standard protein levels

Containing standard protein levels to target normal protein amount of 0.8 g of protein/kg body weight/day

DIETARY_SUPPLEMENTNutritionally complete Tube Feed with higher protein levels

Containing higher protein levels to target elevated protein amount of 1.3 g of protein/kg body weight/day.


Locations(1)

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, Belgium

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NCT06714240


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