Nutrient Uptake During Continuous Enteral Feeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous enteral feeding.
- Who it may be relevant to
- Registry conditions: Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Uptake of Glucose and Phenylalanine From Continuous Enteral Nutrition in Healthy and Critically Ill Persons
Overview
Continuous enteral nutrition is used to feed patients in intensive care who are unable to eat normally. The goal of this observational study is to learn about the uptake of nutrients from feeding formula. The study method will first be applied in healthy persons to establish workability and normal values, then in patients in the intensive care unit to learn how nutrient uptake is affected by critical illness. The main questions this study aims to answer are: * what is the time course of uptake of phenylalanine (an amino acid) and glucose (a sugar) from enteral feeding formula given continuously over several hours * what is the time course of the filling volume of the stomach during continuous enteral feeding Participants receive feeding formula through a nasogastric feeding tube and blood samples are taken at short intervals to analyse uptake of nutrients into blood. Simultaneously, the filling volume of the stomach is measured by gastric ultrasound.
Detailed description
Background
The investigators have previously studied the uptake of dietary isotope-labeled phenylalanine and plasma amino acid concentrations in critically ill patients and healthy subjects. During continuous feeding, uptake was unexpectedly found to be highly variable over time. Due to infrequent sampling, the time course of variability could not be modeled mathematically. Also, the underlying physiological mechanisms remain unclear, though it is hypothesized that gastric emptying is a major factor determining temporal variability.
The study here described is a follow-up that includes serial abdominal ultrasound studies to measure gastric emptying, additional indicators/tracers to determine more detail of uptake vs. digestion/transport/metabolism, and makes use of more frequent sampling to allow for detailed mathematical modeling of temporal variability.
Experimental protocol
ICU patients:
* Standard care and treatment as per clinical routines * Pre-experiment ongoing nutrition for ≥ 6 hrs by nasogastric feeding tube or gastrostomy (not postpyloric) * Bed rest during experiment as feasible
Healthy subjects
* Keep dietary and training habits for ≥ 2 days before experiment start * Overnight fast * Bed rest during experiment as feasible * Nasogastric feeding tube * Arterial line in radial or ulnar artery
Nutrition, sampling, measurements
* Experimental nutrition by continuous infusion for 10 hrs * Infusion rate corresponding to 25 kcal/kg body weight/day (calculated including metabolizable tracers/indicators) * Arterial blood sampling (à 1 ml) every 5 min in pilot study (may adjust to 10 or 15 min depending on results of pilot study) * Serial abdominal ultrasound for determination of gastric volume (pilot study will determine how often)
Experimental nutrition
* Commercially available feeding formula for ICU use (Fresubin® HP Energy or similar) with added phenylalanine and glucose indicators * Intrinsically labeled protein: 13C-L-phenylalanine intrinsically labeled milk protein * Nonmetabolisable phenylalanine analogue: D-phenylalanine * Free amino acid tracer: stable isotope-labeled phenylalanine tracer (2H5-L-Phe) * Non-metabolizable glucose analogue: 3-O-Methyl-d-glucose (3-OMG) * Free glucose tracer: isotope labeled D-glucose
Analyses
* arterial plasma amino acid and glucose tracers as above * arterial plasma 3-OMG * arterial plasma aminograms * arterial plasma glucose, insulin, c peptide
Interventions
- Procedure Continuous enteral feeding
Enteral nutrition by continuous infusion for 10 hrs at a dose corresponding to 25 kcal/kg body weight/day
Primary outcome measures
- Glucose and phenylalanine indicators [Time frame: 0-10 hours]
- Gastric volume [Time frame: 0-10 hours]
Secondary outcome measures (1)
- Plasma metabolites [Time frame: 0-10 hours]
Eligibility criteria
Inclusion Criteria (ICU patients):
\- stable enteral nutrition of >80% of measured or calculated energy expenditure by nasogastric feeding tube or gastrostomy
Exclusion Criteria (ICU patients):
- enteral nutrition by postpyloric route such as jejunostomy or postpyloric tube
- remaining ICU stay expected < 12 hrs
- ongoing bleeding that requires surgery/intervention or transfusion of > 2 units red cells/24 hrs
- inability to use feeding tube or arterial line
Inclusion Criteria (healthy subjects):
\- healthy volunteer
Exclusion Criteria (healthy subjects)
\- any condition or medication affecting nutrition or metabolism
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Liebau F, Kiraly E, Olsson D, Wernerman J, Rooyackers O. Uptake of dietary amino acids into arterial blood during continuous enteral feeding in critically ill patients and healthy subjects. Clin Nutr. 2021 Mar;40(3):912-918. doi: 10.1016/j.clnu.2020.06.018. Epub 2020 Jun 30. PMID 32709553
Identifiers
NCT: NCT05628844 · 2022-04200-01