High Enteral Protein NutritionNCT02678325
The Basel Enteral High Protein Study
A study testing Standardized high protein enteral nutrition and Standardized normal protein enteral nutrition in people with High Enteral Protein Nutrition and Muscle Breakdown, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Enteral Protein Nutrition, Muscle Breakdown, Autophagy
- What is being tested?
- Standardized high protein enteral nutrition and Standardized normal protein enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 May 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients (age 18 years or older)
- expected stay at the ICU of four days upon admittance or longer
- expected enteral feeding during at least four days.
Who cannot join
- BMI ≤ 18
- Mechanical intestinal obstruction
- Intestinal perforation
- Severely impaired liver function
- Terminal state of consuming disease
- Noradrenaline ≥0.5µg/kg BW/min
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance of Early High Protein Nutrition of the Critically Ill: Comparison of a Protein-rich Enteral Formula With a Standardized High Carbohydrate Product on Total Calorie and Protein Intake
The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml.
The total amount of protein taken in on day four after starting the early enteral feeding is defined as primary endpoint.
Read the detailed description
For years, the Surgical Intensive Care Unit of the University Hospital Basel has used an early enteral approach for the feeding of critically ill patients with different formulas that have high protein content (20% of total energy). However, the energy goal in the first week is only 20 kcal for normal-weight and 12.5 kcal for obese patients, which results in daily protein amounts of 0.8 to 1 g/kg bodyweight (BW), so that additional protein has to be administered. Due to a suggestion of the dietetic service of the University Hospital Basel, Fresenius Kabi produced a whey based enteral feeding formula for intensive care patients. Specific further adaptations for this patient group included micronutrients and a fatty acid profile as well as low fibres. Surgical Intensive Care Unit of the University Hospital Basel now are offered the opportunity to test this formula in clinical practice and hypothesize that this specific high-protein (30% of energy) enteral formula reaches the same amount of daily caloric intake with a higher total daily amount of protein and equal intestinal tolerance compared to a usual intestinal nutritional formula.
In order to test this hypothesis, investigators plan a double-blind, randomized and controlled study with the aim to achieve a target protein quantity of ≥1.3 g/kg BW with an energy target of 20kcal/kg BW per day, based on a new, specifically designed formula for critically ill patients. The amount of protein on day four after starting the early enteral feeding is defined as primary endpoint. Secondary endpoints are the total amount of calories, the nitrogen balance on day five as well as side effects like gastric residual content, diarrhoea and constipation. Inclusion criteria were an expected stay at the ICU of four days or longer on admission and 18 years of age or older Exclusion criteria consisted of BMI ≤ 18, pregnancy, intestinal perforation, mechanical intestinal obstruction, terminal state of consuming disease, severely impaired liver function and noradrenaline ≥0.5µg/kg BW/min.. On this purpose, 90 critically ill patients will get either of the two enteral feeding products as described above. In case of the event that an increased protein intake can be obtained by the protein-rich formula, an additional study will investigate the influence of early protein-rich nutrition on skeletal muscle wasting with critically ill patients.
In a pre-study investigators will administer the high protein formula to 20 patients to test tolerance and suitability for the nutritional Targets in question. Tolerance will be defined by the absence of one of the following clinical symptoms :
- Reflux
- Diarrhoea
- Constipation
- Nausea
- Vomiting
- Conditions
- High Enteral Protein Nutrition, Muscle Breakdown, Autophagy
- Being tested
- Standardized high protein enteral nutrition, Standardized normal protein enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized high protein enteral nutritionOther
A double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality.
Standardized normal protein enteral nutritionOther
double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality.
| Study group | Role | What they receive |
|---|---|---|
| Standardized normal protein enteral nutrition formula | Active comparator | Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 20% of the total caloric intake Receives: Other: Standardized normal protein enteral nutrition |
| Standardized high protein enteral nutrition formula | Experimental | Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake Receives: Other: Standardized high protein enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of protein
The amount of protein administered on day four after starting the early enteral feeding.
Measured: 4 days
Secondary outcomes (5)
The total amount of calories
Indirect Calorimetry
Measured: 4 days
The nitrogen balance on day four
Nitrogen input - nitrogen loss measured over 4 days
Measured: 4 days
Gastric residual Content in ml
ml
Measured: 4 days
Number of diarrhea events
Number
Measured: 4 days
occurence of constipation as measured in time without defecation
time frame without defecation
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start21 May 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 High Enteral Protein NutritionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Siegemund, Prof. Dr. MD, Study director, Deputy Chief Physician, Surgical Intensive Care Unit, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678325
- Sponsor's protocol ID
- 2016-00041
- Other IDs
- 2016
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2016
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tedeschi-Jockers F, Reinhold S, Hollinger A, Tuchscherer D, Kiss C, Gantner L, Ledergerber K, Zimmermann S, Scheuzger J, Huber J, Siegemund M. A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in critically ill patients: a prospective observational tolerability study. Eur J Clin Nutr. 2022 Mar;76(3):419-427. doi: 10.1038/s41430-021-00956-9. Epub 2021 Jun 24.
PubMed 34168292
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Early High Protein Nutrition of the Critically Ill: Comparison of a Protein-rich Enteral Formula With a Standardized High Carbohydrate Product on Total Calorie and Protein Intake
- ClinicalTrials.gov ID
- NCT02678325
- Acronym / sponsor ID
- 2016-00041
- Conditions
- High Enteral Protein Nutrition, Muscle Breakdown, Autophagy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 May 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml.
The total amount of protein taken in on day four after starting the early enteral feeding is defined as primary endpoint.
Detailed description
For years, the Surgical Intensive Care Unit of the University Hospital Basel has used an early enteral approach for the feeding of critically ill patients with different formulas that have high protein content (20% of total energy). However, the energy goal in the first week is only 20 kcal for normal-weight and 12.5 kcal for obese patients, which results in daily protein amounts of 0.8 to 1 g/kg bodyweight (BW), so that additional protein has to be administered. Due to a suggestion of the dietetic service of the University Hospital Basel, Fresenius Kabi produced a whey based enteral feeding formula for intensive care patients. Specific further adaptations for this patient group included micronutrients and a fatty acid profile as well as low fibres. Surgical Intensive Care Unit of the University Hospital Basel now are offered the opportunity to test this formula in clinical practice and hypothesize that this specific high-protein (30% of energy) enteral formula reaches the same amount of daily caloric intake with a higher total daily amount of protein and equal intestinal tolerance compared to a usual intestinal nutritional formula.
In order to test this hypothesis, investigators plan a double-blind, randomized and controlled study with the aim to achieve a target protein quantity of ≥1.3 g/kg BW with an energy target of 20kcal/kg BW per day, based on a new, specifically designed formula for critically ill patients. The amount of protein on day four after starting the early enteral feeding is defined as primary endpoint. Secondary endpoints are the total amount of calories, the nitrogen balance on day five as well as side effects like gastric residual content, diarrhoea and constipation. Inclusion criteria were an expected stay at the ICU of four days or longer on admission and 18 years of age or older Exclusion criteria consisted of BMI ≤ 18, pregnancy, intestinal perforation, mechanical intestinal obstruction, terminal state of consuming disease, severely impaired liver function and noradrenaline ≥0.5µg/kg BW/min.. On this purpose, 90 critically ill patients will get either of the two enteral feeding products as described above. In case of the event that an increased protein intake can be obtained by the protein-rich formula, an additional study will investigate the influence of early protein-rich nutrition on skeletal muscle wasting with critically ill patients.
In a pre-study investigators will administer the high protein formula to 20 patients to test tolerance and suitability for the nutritional Targets in question. Tolerance will be defined by the absence of one of the following clinical symptoms :
- Reflux
- Diarrhoea
- Constipation
- Nausea
- Vomiting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized normal protein enteral nutrition formula | Active comparator | Other: Standardized normal protein enteral nutritionStandardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 20% of the total caloric intake |
| Standardized high protein enteral nutrition formula | Experimental | Other: Standardized high protein enteral nutritionStandardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age 18 years or older)
- expected stay at the ICU of four days upon admittance or longer
- expected enteral feeding during at least four days.
Key exclusion criteria (7 listed)
- BMI ≤ 18
- Mechanical intestinal obstruction
- Intestinal perforation
- Severely impaired liver function
- Terminal state of consuming disease
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 |
|---|---|---|
| Standardized high protein enteral nutritionA double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality. | Other | Standardized high protein enteral nutrition formula |
| Standardized normal protein enteral nutritiondouble-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality. | Other | Standardized normal protein enteral nutrition formula |
Primary outcome
The amount of protein
Time frame: 4 days
The amount of protein administered on day four after starting the early enteral feeding.
5 secondary outcomes
The total amount of calories
Time frame: 4 days
The nitrogen balance on day four
Time frame: 4 days
Gastric residual Content in ml
Time frame: 4 days
Number of diarrhea events
Time frame: 4 days
occurence of constipation as measured in time without defecation
Time frame: 4 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 34168292Tedeschi-Jockers F, Reinhold S, Hollinger A, Tuchscherer D, Kiss C, Gantner L, Ledergerber K, Zimmermann S, Scheuzger J, Huber J, Siegemund M. A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in critically ill patients: a prospective observational tolerability study. Eur J Clin Nutr. 2022 Mar;76(3):419-427. doi: 10.1038/s41430-021-00956-9. Epub 2021 Jun 24.
- Individual participant dataSharing planned: No
Related trials for High Enteral Protein Nutrition
Not yet recruitingPhase 4
A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
High-risk Patients With Pancreatic Exocrine Insufficiency, Enteral Nutrition Feeding
Enrolling by invitation
Evaluating Benefit of Peptide Based Diet in Obese HEN Patients
Obesity
Enrolling by invitation
High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
Handgrip Strength
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. This study is not recruiting at the moment.
Martin Siegemund, Prof. Dr. MD study director
Deputy Chief Physician, Surgical Intensive Care Unit, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized high protein enteral nutrition and Standardized normal protein enteral nutrition in people with High Enteral Protein Nutrition and Muscle Breakdown, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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: stopped early, as of the sponsor's last update on 30 Mar 2021. 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 Switzerland. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of protein (time frame: 4 days). 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 NCT02678325, 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 30 Mar 2021.