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Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness

NCT04791774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-10

No results posted yet for this study

Summary

In the current study, we willquantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in critically ill patients admitted to the intensive care unit suffering from malabsorption. 16 adult, mechanically ventilated ICU patients with clinical signs of malabsorption (faecal weight \>350 g/day) will be included. All patients will receive a primed continuous intravenous infusion of L-\[ring2H5\]-phenylalanine and L-\[3,5-2H2\]-Tyrosine for the duration of the study period. After reaching an isotopic steady state (1.5 hours), patients will receive either \[1-13C\]- phenylalanine labelled milk protein or free amino acids with an identical constitution and \[1-13C\]-phenylalanine.

Main study endpoint will be the splanchnic extraction of phenylalanine, calculated from systemic \[1-13C\]- and L-\[ring2H5\]-phenylalanine enrichment.

Conditions

  • Intestinal Malabsorption
  • Critical Illness
  • Protein Malnutrition

Interventions

DIETARY_SUPPLEMENT

Milk protein (food grade protein)

Subjects will receive an enteral nutritional formula containing 20 grams intrinsically labeled (1-\[13C\]-phenylalanine) milk protein

DIETARY_SUPPLEMENT

Fee amino acids (food grade amino acids)

Nutritional formula containing 20 grams of a free amino acid mixture equivalent in composition to the milk protein with 1-\[13C\]-labeled phenylalanine

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marcel van de Poll, MD, PhD · Maastricht University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791774 on ClinicalTrials.gov