Higher versus standard protein by feeding tube to boost muscle protein synthesis in ICU patients
Official title: Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients
Run by Maastricht University Medical Center · NCT06714240 · Data updated 2026-11-12
This will test whether giving ventilated, critically ill adults more protein through a feeding tube (about 1.3 g/kg/day) helps their muscles make more protein over four days than standard protein (about 0.8 g/kg/day).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Hasselt, Limburg) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | October 2027 |
| Study ends | September 2028 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT06714240 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) in the ICU who are mechanically ventilated, suitable for enteral nutrition, expected to need at least three more days of ventilation and an ICU stay of at least seven days.
✕Probably not a fit
Patients with morbid obesity (BMI ≥40), spinal cord injury, chronic pre-admission corticosteroid use, severe kidney or liver failure, dialysis requirements, major allergies/intolerances to feed components, or bleeding/anticoagulant disorders are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional study will assign 26 mechanically ventilated, enterally fed ICU patients to receive either a standard protein enteral formula (target 0.8 g/kg/day) or a higher-protein enteral formula (target 1.3 g/kg/day). Muscle protein synthesis rates will be measured over a four-day intervention period to compare anabolic responses between groups. Eligible participants are adults expected to require at least three days of mechanical ventilation and a minimum seven-day ICU stay, with several medical exclusions to ensure safety. The trial is conducted at a single center and powered for short-term biologic outcomes rather than long-term functional recovery.
Why it matters
Potential benefit: If successful, the intervention could reduce ICU-related muscle wasting and help patients regain strength and physical function more quickly after critical illness.
How similar studies have gone: Previous trials of higher protein intake in critically ill patients have produced mixed results and anabolic resistance is a known issue, so evidence is currently conflicting and this direct comparison addresses that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Jessa Hospital Campus Virga Jesse
Hasselt, Limburg, Belgium Recruiting
Study contacts
- Study coordinator: Michèlle Hendriks, MSc
- Email: michelle.hendriks@maastrichtuniversity.nl
- Phone: +31 43 388 1184
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.