Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

ConditionsCritical Illness Muscle Protein Synthetic Response to Protein

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Nutritionally complete Tube Feed with standard protein levels
Dietary supplement
Containing standard protein levels to target normal protein amount of 0.8 g of protein/kg body weight/day
Nutritionally complete Tube Feed with higher protein levels
Dietary supplement
Containing higher protein levels to target elevated protein amount of 1.3 g of protein/kg body weight/day.

Treatment groups

26 Participants

are divided into 2 treatment groups

Group A: Normal protein amountActive comparator 1 intervention

Group B: Elevated protein amountExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Myofibrillar protein fractional synthetic rate

The myofibrillar protein synthesis rates are calculated using D2O.

Time frame

1-4 days

Secondary outcomes

Mixed muscle protein fractional synthetic rate

The mixed muscle protein synthesis rates are calculated using D2O.

Time frame

1-4 days

Plasma amino acids concentrations

Determining differences in plasma amino acids concentration between groups receiving normal versus elevated protein levels through enteral nutrition

Time frame

1-4 days

Muscle fiber size in µm²

Muscle fiber size will be assessed using immunofluorescence staining.

Time frame

Final intervention day (after 4 days of enteral feeding)

Proportion (%) of muscle fiber types (type I and type II)

Fiber proportion will be assessed using immunofluorescence staining.

Time frame

Final intervention day (after 4 days of enteral feeding)

Other outcomes

Age in years

Heteroanamnesia

Time frame

Baseline

Body mass in kg

Heteroanamnesia

Time frame

Baseline

Height in m

Heteroanamnesia

Time frame

Baseline

BMI in kg/m²

Calculated from height and body mass

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

Danone Global Research & Innovation Center

Collaborator

Source ClinicalTrials.gov

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