Critical IllnessNCT05628844
Nutrient Uptake During Continuous Enteral Feeding
An observational study of Critical Illness, run by Felix Liebau.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Continuous enteral feeding
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ICU patients: patients admitted to an intensive care unit at Karolinska University Hospital Healthy subjects: volunteers from Stockholm metropolitan region
Who may be able to join
- stable enteral nutrition of >80% of measured or calculated energy expenditure by nasogastric feeding tube or gastrostomy
- healthy volunteer
Who cannot join
- 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
- any condition or medication affecting nutrition or metabolism
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Felix Liebau, MD PhD contact
About this study
Official title: Uptake of Glucose and Phenylalanine From Continuous Enteral Nutrition in Healthy and Critically Ill Persons
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:
Read more
- 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.
Read the 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
- Conditions
- Critical Illness
- Being tested
- Continuous enteral feeding
- Keywords
- Continuous enteral feeding, Gastric volume, Intestinal absorption, Enteral nutrition, Nutritional support
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous enteral feedingProcedure or surgery
Also called Gastric ultrasound
Enteral nutrition by continuous infusion for 10 hrs at a dose corresponding to 25 kcal/kg body weight/day
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy persons ≥ 18 yrs of age Receives: Procedure: Continuous enteral feeding | |
| Critically ill patients | Critically ill patients ≥ 18 yrs of age admitted to the ICU Receives: Procedure: Continuous enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and phenylalanine indicators
Time series of isotopic and non-isotopic indicators of glucose and phenylalanine from enteral nutrition
Measured: 0-10 hours
Gastric volume
Time series of gastric volume
Measured: 0-10 hours
Secondary outcomes (1)
Plasma metabolites
Time series of plasma aminograms, glucose, insulin and c peptide
Measured: 0-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix Liebau
- Sponsor type
- Other government
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Responsible party
- Sponsor-investigator, Felix Liebau, Region Stockholm
- Investigators
- Felix Liebau, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628844
- Sponsor's protocol ID
- 2022-04200-01
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32709553
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake of Glucose and Phenylalanine From Continuous Enteral Nutrition in Healthy and Critically Ill Persons
- ClinicalTrials.gov ID
- NCT05628844
- Acronym / sponsor ID
- 2022-04200-01
- Conditions
- Critical Illness
- Keywords
- Continuous enteral feeding, Gastric volume, Intestinal absorption, Enteral nutrition, Nutritional support
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Felix LiebauOther government
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Procedure: Continuous enteral feedingHealthy persons ≥ 18 yrs of age |
| Critically ill patients | – | Procedure: Continuous enteral feedingCritically ill patients ≥ 18 yrs of age admitted to the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients: patients admitted to an intensive care unit at Karolinska University Hospital Healthy subjects: volunteers from Stockholm metropolitan region
Key inclusion criteria (2 listed)
- stable enteral nutrition of >80% of measured or calculated energy expenditure by nasogastric feeding tube or gastrostomy
- healthy volunteer
Key exclusion criteria (5 listed)
- 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
- any condition or medication affecting nutrition or metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous enteral feedingAlso: Gastric ultrasoundEnteral nutrition by continuous infusion for 10 hrs at a dose corresponding to 25 kcal/kg body weight/day | Procedure or surgery | Critically ill patients, Healthy subjects |
Primary outcome
Glucose and phenylalanine indicators
Time frame: 0-10 hours
Time series of isotopic and non-isotopic indicators of glucose and phenylalanine from enteral nutrition
Gastric volume
Time frame: 0-10 hours
Time series of gastric volume
1 secondary outcome
Plasma metabolites
Time frame: 0-10 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Background: PubMed 32709553Liebau 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Liebau, MD PhD contact
Felix Liebau, MD PhD principal investigator
Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Felix Liebau.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Felix Liebau, MD PhD (felix.liebau@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose and phenylalanine indicators (time frame: 0-10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628844, which also lists 1 linked publication.
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 2 Dec 2022.