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Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

Study acronym: IPA-IC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Mar 2025 to Sep 1, 2025
    • Study completion date: Oct 2028 to Sep 2028
    • Site details revised
    • Collaborator revised
  2. Re-verified, no change to tracked fieldsv3
  3. Start date: Feb 2025 to Mar 2025v2 Show 6 more changesShow less
    • Interventions: Elevated protein amount (Dietary Supplement), Normal protein amount (Dietary Supplement) to Nutritionally complete Tube Feed with higher protein levels (Dietary Supplement), Nutritionally complete Tube Feed with standard protein…
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site contact updated
    • Collaborator revised
    • Study description shortened, about 1 word
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06714240
Lead Sponsor Maastricht University Medical Center
Collaborators: Danone Global Research & Innovation Center
Conditions
(from sponsor)		 Critical Illness, Muscle Protein Synthetic Response to Protein
Related terms Critical Illness
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov