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AzTrials

Critical IllnessIPA-ICNCT06714240

Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU

A study testing Nutritionally complete Tube Feed with standard protein levels and Nutritionally complete Tube Feed with higher protein levels in people with Critical Illness and Muscle Protein Synthetic Response to Protein, run by Maastricht University Medical Center at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nutritionally complete Tube Feed with standard protein levels and Nutritionally complete Tube Feed with higher protein levels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteBelgium
Study dates
1 Sep 2025to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site, 1 recruiting
  • Jessa Hospital Campus Virga Jesse

    Hasselt, Limburg, 3500

    Björn Stessel, Prof. Dr., +3211 33 55 77, bjorn.stessel@jessazh.be

    Michèlle Hendriks, MSc, +31 43 388 1184, michelle.hendriks@maastrichtuniversity.nl

    Recruiting

Other trials in Belgium

About this study

Official title: Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients

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.

Read more

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.

Read the detailed description

Complexities of Critical Illness - Critical illness encompasses the progression of severe medical conditions like major trauma or sepsis, which disrupt the body's homeostasis. This imbalance increases susceptibility to vital organ dysfunction, thereby posing imminent life-threatening consequences without prompt intensive medical support in hospitals. A key concern in critically ill patients is the rapid onset of skeletal muscle wasting, resulting in a condition known as intensive care unit-acquired weakness (ICU-AW). This muscle weakness is closely associated with extended mechanical ventilation and higher morbidity and mortality rates. Even after recovery, patients often suffer from long-term physical impairments and disabilities, resulting in post-intensive care syndrome (PICS), a condition characterized by persistent and debilitating consequences of ICU admission. Muscle weakness can last several years after ICU discharge, contributing to increased healthcare costs and a reduced quality of life. Considering the profound impact on both short- and long-term outcomes, coupled with the absence of effective strategies to prevent muscle wasting and weakness, remain major challenges in modern intensive care medicine.

Skeletal Muscle Protein Imbalance - Skeletal muscle mass is regulated by the balance between muscle protein synthesis, degradation, and folding. Under stable conditions, proteins serve structural and functional purposes crucial for growth, recovery, and adaptation. However, critical illness alters protein dynamics. Disturbance in protein folding can result in the accumulation of damaged proteins, causing a decline in protein quality, while imbalances between protein synthesis and degradation can lead to a decrease in quantity. Critically ill patients often experience a metabolic shift towards a catabolic state, wherein skeletal muscles are broken down to fulfill energy demands. Notably, during this catabolic phase, muscle proteins become a primary fuel source, with rates of muscle protein breakdown surpassing those of synthesis. This rapid muscle protein loss can result in up to 18% reduction in muscle mass within the first 10 days of ICU stay, ultimately leading to muscle atrophy.

Previous research has utilized nitrogen balance assessments and stable isotope techniques to evaluate whole-body protein turnover. However, only a few studies have specifically measured muscle protein synthesis (MPS) rates in critically ill patients using intravenous stable isotope infusions. These measurements typically cover short durations (less than 9 hours), making it challenging to extrapolate the findings to long-term outcomes due to the inherent limitations of amino acid tracer techniques. Adaptions to muscle disuse, inflammation, and catabolic stress likely occur over several days or weeks rather than hours. A promising alternative is oral deuterated water (D2O), which enables the assessment of MPS over longer periods (days or weeks). Current research by our group used D2O to provide insights into muscle synthesis rates over multiple ICU days. This pioneering study will establish critical baseline data for future research.

Protein Ingestion as a Key Modulator - To improve patient recovery, interventions targeting muscle loss are recommended. The 2019 guidelines from the European Society for Clinical Nutrition and Metabolism (ESPEN) emphasize the importance of nutritional support for mechanically ventilated ICU patients. Specifically, dietary proteins and their amino acid composition are key in mitigating skeletal muscle wasting and improving long-term clinical outcomes. However, the efficacy of dietary protein to stimulate MPS is regulated by various physiological factors such as dietary protein digestion and amino acid absorption, splanchnic amino acid retention, postprandial insulin release, skeletal muscle tissue perfusion, amino acid uptake by muscle, and intramyocellular signaling. Current international guidelines recommend elevated protein intake for critically ill patients, ranging from 1.2 to 2.0 g protein/kg body weight/day, exceeding recommendations for healthy individuals. However, while higher protein intake has been shown to enhance MPS, recent research suggests that the upper threshold of 2.0 g/kg/day may negatively impact health-related quality of life without improving functional outcomes up to 180 days post-ICU admission. Given these conflicting findings, the precise impact of elevated protein intake on MPS in critically ill patients remains unclear, warranting further investigation to determine the optimal protein requirements during critical illness. Furthermore, despite these widely accepted guidelines and intake recommendations, observational studies have reported that actual protein intake in ICU patients often falls below these targets, ranging from 0.7 to 1.2 g/kg/day. Recent research demonstrated efficient digestion and absorption of enterally administered protein. Nevertheless, post-prandial muscle protein synthesis rates were much lower in critically ill patients than in healthy volunteers. This indicates that critical illness does not impair dietary protein digestion and amino acid absorption. However, incorporating dietary protein-derived amino acids into skeletal muscle protein is blunted, representing anabolic resistance to dietary protein. This anabolic resistance underscores the complexity of muscle protein metabolism in critically ill patients and highlights the need for effective strategies to attenuate skeletal muscle wasting.

In short, this prospective study aims to evaluate the effect of normal vs. elevated enteral protein administration on muscle protein synthesis rates and muscle characteristics in critically ill patients. This research will provide valuable insights to develop effective nutritional interventions to address skeletal muscle wasting in critical illness.

Being tested
Nutritionally complete Tube Feed with standard protein levels, Nutritionally complete Tube Feed with higher protein levels
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritionally complete Tube Feed with standard protein levelsDietary supplement

    Containing standard protein levels to target normal protein amount of 0.8 g of protein/kg body weight/day

  • Nutritionally complete Tube Feed with higher protein levelsDietary supplement

    Containing higher protein levels to target elevated protein amount of 1.3 g of protein/kg body weight/day.

Study groups in NCT06714240
Study groupRoleWhat they receive
Normal protein amountActive comparatorNot described
Receives: Dietary Supplement: Nutritionally complete Tube Feed with standard protein levels
Elevated protein amountExperimentalNot described
Receives: Dietary Supplement: Nutritionally complete Tube Feed with higher protein levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myofibrillar protein fractional synthetic rate

    The myofibrillar protein synthesis rates are calculated using D2O.

    Measured: 1-4 days

Secondary outcomes (6)
  1. Mixed muscle protein fractional synthetic rate

    The mixed muscle protein synthesis rates are calculated using D2O.

    Measured: 1-4 days

  2. Plasma amino acids concentrations

    Determining differences in plasma amino acids concentration between groups receiving normal versus elevated protein levels through enteral nutrition

    Measured: 1-4 days

  3. Muscle fiber size in µm²

    Muscle fiber size will be assessed using immunofluorescence staining.

    Measured: Final intervention day (after 4 days of enteral feeding)

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

    Fiber proportion will be assessed using immunofluorescence staining.

    Measured: Final intervention day (after 4 days of enteral feeding)

  5. Myonuclei quantity

    Myonuclei quantity will be assessed using immunofluorescence staining.

    Measured: Final intervention day (after 4 days of enteral feeding)

  6. Mitochondrial respiration

    Mitochondrial respiration will be assessed using Oroboros Instruments (Oroboros O2k FluoRepirometer).

    Measured: Final intervention day (after 4 days of enteral feeding)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start1 Sep 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a prospective, randomized, longitudinal, controlled interventional trial with a parallel-group design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714240
Sponsor's protocol ID
2024/223
Acronym
IPA-IC
Status last verified
Oct 2025
First submitted
20 Nov 2024
Last updated
10 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritionally complete Tube Feed with standard protein levels and Nutritionally complete Tube Feed with higher protein levels in people with Critical Illness and Muscle Protein Synthetic Response to Protein, run by Maastricht University Medical Center at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michèlle Hendriks, MSc (+31 43 388 1184, michelle.hendriks@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myofibrillar protein fractional synthetic rate (time frame: 1-4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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