Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06714240

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

Led by Maastricht University Medical Center · Updated on 2025-12-10

26

Participants Needed

1

Research Sites

48 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

Researchers are investigating the impact of protein intake on muscle protein synthesis (MPS) in critically ill patients. These patients often experience rapid muscle loss, leading to long-term weakness and complications such as ICU-acquired weakness (ICU-AW) and post-intensive care syndrome (PICS). The study focuses on whether normal protein intake versus elevated protein intake can improve muscle protein synthesis rates during critical illness, aiming to find better nutritional strategies to reduce muscle wasting. Participants will be randomly assigned to one of two groups receiving enteral nutrition with different protein targets: a normal protein intake group aiming for 0.8 g protein/kg/day and an elevated protein intake group aiming for 1.3 g protein/kg/day. Both groups will receive nutritionally complete tube feeds formulated to meet these protein targets. The intervention period lasts four days, during which muscle biopsies and blood samples will be collected to assess muscle protein synthesis and muscle characteristics. During the study, patients will be monitored closely in the ICU, with muscle biopsies and blood tests performed to measure muscle protein synthesis rates and muscle health indicators such as muscle fiber size and mitochondrial function. Researchers will evaluate the primary outcome of myofibrillar protein fractional synthetic rate over 1 to 4 days. Secondary measures include mixed muscle protein synthesis, plasma amino acid levels, muscle fiber types and size, myonuclei quantity, and mitochondrial respiration. The study aims to improve knowledge on protein needs in critical illness over a typical ICU stay of at least seven days, with participants requiring mechanical ventilation for a minimum of three days.

CONDITIONS

Brief Title

Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Suitable for enteral nutrition without gastrointestinal failure or complete intestinal obstruction
  • Expected to require mechanical ventilation for at least three days
  • Expected to stay in the intensive care unit for at least seven days
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) of 40 kg/m² or higher
  • Spinal cord injury
  • Chronic use of corticosteroids before hospital admission
  • Severe allergies or intolerances to cow's milk protein, fish, soy, pea protein, or galactosemia
  • Severe kidney or liver failure
  • Requirement for dialysis
  • Bleeding disorders or use of anticoagulant or antiplatelet therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 days

Participants receive enteral feeding with either normal or elevated protein amounts to evaluate muscle protein synthesis rates.

Daily assessments during feeding period

Trial Site Locations

Total: 1 location

1

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

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Research Team

M

Michèlle Hendriks, MSc

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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