Higher versus standard protein by feeding tube to boost muscle protein synthesis in ICU patients
Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients
NA · Maastricht University Medical Center · NCT06714240
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center (other) |
| Locations | 1 site (Hasselt, Limburg) |
| Trial ID | NCT06714240 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hasselt, Limburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Illness, Muscle Protein Synthetic Response to Protein