Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

NCT06714240 | Recruiting

• 1 other identifier: 2024/223
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Muscle Protein Synthetic Response to Protein

Outcome Measures

Primary Outcomes (1)

• Myofibrillar protein fractional synthetic rate

  The myofibrillar protein synthesis rates are calculated using D2O.

  1-4 days

Secondary Outcomes (6)

• Mixed muscle protein fractional synthetic rate

  1-4 days

• Plasma amino acids concentrations

  1-4 days

• Muscle fiber size in µm²

  Final intervention day (after 4 days of enteral feeding)

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

  Final intervention day (after 4 days of enteral feeding)

• Myonuclei quantity

  Final intervention day (after 4 days of enteral feeding)

Other Outcomes (5)

• Age in years

  Baseline

• Body mass in kg

  Baseline

• Height in m

  Baseline

Study Arms (2)

Normal protein amount

ACTIVE COMPARATOR

Dietary Supplement: Nutritionally complete Tube Feed with standard protein levels

Elevated protein amount

EXPERIMENTAL

Dietary Supplement: Nutritionally complete Tube Feed with higher protein levels

Interventions

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.

Elevated protein amount

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

Normal protein amount

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Jessa Hospital Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michèlle Hendriks, MSc

CONTACT

+31 43 388 1184; michelle.hendriks@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective, randomized, longitudinal, controlled interventional trial with a parallel-group design.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 3, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)