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Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

NCT06714240 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Nutritionally 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_SUPPLEMENT

Nutritionally 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.

Sponsors & Collaborators

  • Danone Global Research & Innovation Center

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-10-31
Completion
2028-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714240 on ClinicalTrials.gov