Actively Recruiting
Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU
Led by Maastricht University Medical Center · Updated on 2025-12-10
26
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
D
Danone Global Research & Innovation Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Suitable for enteral nutrition (no gastrointestinal failure, no complete intestinal obstruction, no major intra-abdominal sepsis)
- Expected to require mechanical ventilation for at least 3 days
- Expected ICU stay of at least 7 days
You will not qualify if you...
- Body mass index (BMI) of 40 kg/m² or higher
- Spinal cord injury
- Chronic corticosteroid use before hospital admission
- Severe allergies or intolerances to cow's milk protein, fish, soy, pea protein, or galactosemia
- Severe kidney and/or liver failure
- Need for dialysis
- Bleeding disorders, including use of anticoagulant or antiplatelet therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jessa Hospital Campus Virga Jesse
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
M
Michèlle Hendriks, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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