NCT06104527

Indicator Amino Acid Oxidation in ICU Patients

The Effect of Standard or Higher Protein Feeding on Indicator Amino Acid Oxidation in ICU Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will use the indicator amino acid oxidation technique (IAAO) to determine protein oxidation of ICU patients at two protein intakes: 1.3 g/kg/d versus 2.0 g/kg/d.

Detailed description

Rationale: While protein administration guidelines for critical care are available from international organizations such as ASPEN and ESPEN, they vary greatly in their recommended dose and are based on relatively low-quality evidence. The Indicator Amino Acid Oxidation (IAAO) technique has been developed as a more practical and non-invasive tool to assess protein metabolism that can be used in vulnerable populations. Application of the IAAO technique in patients admitted to the Intensive Care Unit (ICU) could provide an alternative to better investigate optimal protein feeding during critical illness. Objective: To assess the effect of enteral feeding with higher protein content compared to standard protein content on indicator amino acid oxidation in ICU patients. Study design: Randomized, counterbalanced, cross-over trial. Study population: Adult patients with an unplanned admission to the ICU, who are mechanically ventilated and have an indication for prolonged enteral nutrition. Intervention: Subjects will undergo two test days in randomized order during which they receive either enteral feeding according to a standard protein dose (1.3 g/kg/d) or a higher protein dose (2.0 g/kg/d). Continuous feeding of L-\[1-13C\]-phenylalanine combined with breath, urine and blood samples will be applied to assess indicator amino acid oxidation. Main study parameters/endpoints: The primary endpoint is indicator amino acid oxidation after enteral feeding with a standard or higher protein content, determined using the Indicator Amino Acid Oxidation (IAAO) method by measuring 13CO2 enrichment in expired breath and enrichment of L-\[1-13C\]-phenylalanine in plasma and urine. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The overall risk of the study is negligible. The current study compares the effect of two nutritional compositions, that fall within the recommendations of international guidelines on ICU nutrition, on protein metabolism following ICU admission. To avoid overfeeding in the early phase of critical illness, both in terms of calories and protein, full enteral nutrition is provided after three days of gradual increase of intake (i.e., 25-50-75% of targeted intake, on days 1-2-3 respectively). Sampling of breath, urine, feces and plasma does not bring additional risks for this population. Our department has an extensive background in amino acid stable isotope methodology, assessment of 13CO2 enrichment in expired breath samples, and assessment of carbon dioxide production by indirect calorimetry.

Conditions

• Critical Illness
• Muscle Wasting

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Standard protein enteral nutrition with enteral tracer	Enteral nutrition with standard (1.3 g/kg/d) protein provision, given via a nasogastric tube. An oral L-\[1-13C\]-phenylalanine tracer is given as co-intervention. Use of an enterally given tracer is necessary to determine indicator amino acid oxidation.
COMBINATION_PRODUCT	High protein enteral nutrition with enteral tracer	Enteral nutrition with high (2.0 g/kg/d) protein provision, given via a nasogastric tube. An oral L-\[1-13C\]-phenylalanine tracer is given as co-intervention. Use of an enterally given tracer is necessary to determine indicator amino acid oxidation.

Timeline

• Start date: 2023-10-30
• Primary completion: 2026-03-23
• Completion: 2026-03-23
• First posted: 2023-10-27
• Last updated: 2026-04-17

Locations

1 site across 1 country: Netherlands