Critical IllnessCONVEnIENTNCT07173504
The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients
A study testing Intermittent enteral nutrition in people with Critical Illness, run by Gelderse Vallei Hospital at 5 sites in Netherlands.
Trial summary
The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients. The aim of this study is to: To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Intermittent enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 5 sitesNetherlands
- Study dates
- 30 Sep 2025to Sep 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Receiving or eligible to receive exclusively gastric tube feeding;
- Expected ICU stay ≥48 hours;
- Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission.
Who cannot join
- The treating clinician considers participation in the study clinically contraindicated (e.g., change in feeding regimen, no possibility for placement of CGM on arms, not able to receive exclusive gastric tube feeding);
- Death is deemed to be imminent or inevitable during admission, and the attending doctor, patient, or substitute decision-maker is not committed to active treatment;
- Pregnancy;
- Expected fasting for ≥12 hours during the study period, for example, due to medical procedures;
- Readmission in last 14 days;
- Patients with burn injuries;
- Participating in another nutritional intervention study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Imre WK Kouw contact
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Deventer Ziekenhuis
Deventer, Overijssel, 7416 SE
Arriette Kruisdijk-Gerritsen, 0570535345, A.Gerritsen@dz.nl
Huub van den Oever
- Recruiting
Gelderse Vallei Hospital
Ede, Gelderland, 6716 RP
Arthur RH van Zanten, +3131843115, ZantenA@zgv.nl
- Recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
Martin Rinket, +31650883330, M.Rinket@mst.nl
Bert Beishuizen
- Recruiting
Martini Ziekenhuis
Groningen, Provincie Groningen, 9728NT
Kristine Koekkoek, Dr., 0505245245, kristine.koekkoek@mzh.nl
Kristine Koekkoek
- Recruiting
Haga Ziekenhuis
The Hague, South Holland, 2545 AA
Lettie van den Berg, 070-2108884, A.E.vandenBerg@hagaziekenhuis.nl
Thomas Ottens
About this study
The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients.
The aim of this study is to:
Read more
- To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition.
Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
- Conditions
- Critical Illness
- Being tested
- Intermittent enteral nutrition
- Keywords
- critical illness, tube feeding, glycemic control, chrononutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent enteral nutritionOther
Also called Intermittent tube feeding
Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period.
| Study group | Role | What they receive |
|---|---|---|
| Continuous enteral nutrition | No intervention | Participants will receive the standard of care, continuous enteral nutrition for 24 hours a day. |
| Intermittent enteral nutrition | Experimental | Participants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period. Receives: Other: Intermittent enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic variability
The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels.
Measured: From enrollment to the end of the intervention at a maximum of 5 days.
Secondary outcomes (15)
Glycaemic control
Assessed by mean and standard deviation of interstitial glucose concentrations and Mean Amplitude of Glycaemic Excursions (MAGE) (mmol/L)
Measured: From enrollment to the end of the intervention at a maximum of 5 days
Insulin administred during intervention period
Insulin administred during intervention period (IU/day)
Measured: From enrollment to the end of the intervention at a maximum of 5 days
Dysglycemic events during intervention period
Number of hypoglycaemic events, defined as blood glucose level <4.0 mmol/L and number of hyperglycaemic events, defined as blood glucose level >10.0 mmol/L
Measured: From enrollment to the end of the intervention at a maximum of 5 days
Gastrointestinal tolerance during the intervention period
Gastric residual volumes (mL), minimum, maximum and total volume per 24 hours.
Measured: From enrollment to the end of the intervention at a maximum of 5 days.
Gastrointestinal tolerance during the intervention period
Incidence of vomiting, diarrhoea, constipation and regurgitation during the intervetion periode
Measured: From enrollment to the end of the intervention at a maximum of 5 days
Circadian rhythm
Assessed by 24-hour curves of melatonin ( pg/mL) in saliva.
Measured: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Assessed by 24-hour curves of cortisol( nmol/L) in saliva.
Measured: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Assessed by 24-hour curves of mRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and Per2).
Measured: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Body composition
Fat-free mass, fat mass and skeletal muscle mass (kg and %) by bio-electrical impendence analysis. This outcome is only measured in centres with the necessary equipment.
Measured: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Muscle size
Cross-sectional area and muscle layer thickness of quadriceps muscle by ultrasonography. This outcome is only measured in centres with the necessary equipment.
Measured: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Nutritional intake during intervention period
Total nutritional prescription and delivery per calendar day (energy in kJ/day, protein in g/day, fat in g/day and carbohydrate in g/day and % of total intake)
Measured: From enrollment to the end of the intervention at a maximum of 5 days.
Non-nutritonal calories administred during intervention period
Non-nutritional calories delivered by propofol, glucose infusion, and citrate, delivery in kJ per calendar day
Measured: From enrollment to the end of the intervention at a maximum of 5 days
Health-related quality of life
Health-related quality of life measured with the 36-Item Short Form Health Survey (SF-36), 60 days after ICU admission
Measured: 60 days after ICU admission
Sleep quality
Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI)
Measured: 60 days after ICU admission
Glucoregulatory gastrointestinal hormones
GLP-1, C-peptide, insulin, and glucagon concentrations (mmol/L). This outcome is only measured in the coordinating centre.
Measured: From 12:00 until 14:00 on the second study day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelderse Vallei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Wageningen University and Research
- Responsible party
- Principal investigator, ARH van Zanten, MD PhD, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173504
- Sponsor's protocol ID
- NL88158.091.24
- Acronym
- CONVEnIENT
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07173504
- Acronym / sponsor ID
- CONVEnIENT / NL88158.091.24
- Conditions
- Critical Illness
- Keywords
- critical illness, tube feeding, glycemic control, chrononutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Gelderse Vallei HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Wageningen University and Research
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Sep 2025 (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.
The goal of this clinical trial is to investigate the effect of continuous versus intermittent enteral nutrition on metabolic outcomes in critically ill adult patients.
The aim of this study is to:
- To assess the effect of a daytime intermittent tube feeding pattern compared to standard continuous tube feeding on glycaemic control, gastrointestinal function, gastrointestinal hormones, markers of sleep quality and circadian rhythm, and lean body mass and body composition.
Participants will receive either continuous enteral nutrition for 24 hours a day or intermittent enteral nutrition during the day, consisting of 4 portions each administered over 1 hour between 8 am and 8 pm. The maximum duration of the intervention is 5 days or until participants do not receive exclusive gastric enteral nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous enteral nutrition | No intervention | –Participants will receive the standard of care, continuous enteral nutrition for 24 hours a day. |
| Intermittent enteral nutrition | Experimental | Other: Intermittent enteral nutritionParticipants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Receiving or eligible to receive exclusively gastric tube feeding;
- Expected ICU stay ≥48 hours;
- Receiving or anticipated to receive invasive mechanical ventilation within 48 hours after ICU admission.
Key exclusion criteria (7 listed)
- The treating clinician considers participation in the study clinically contraindicated (e.g., change in feeding regimen, no possibility for placement of CGM on arms, not able to receive exclusive gastric tube feeding);
- Death is deemed to be imminent or inevitable during admission, and the attending doctor, patient, or substitute decision-maker is not committed to active treatment;
- Pregnancy;
- Expected fasting for ≥12 hours during the study period, for example, due to medical procedures;
- Readmission in last 14 days;
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 |
|---|---|---|
| Intermittent enteral nutritionAlso: Intermittent tube feedingParticipants will receive intermittent enteral nutrition in four separate portions between 8:00 a.m. and 8:00 p.m. Each portion will be administered over a one-hour period. | Other | Intermittent enteral nutrition |
Primary outcome
Glycaemic variability
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
The primary outcome is the mean glycaemic variability per 24 hours during the intervention, measured with Continuous Glucose Monitoring (CGM), expressed as the Coefficient of Variation (COV). The COV is calculated by dividing the standard deviation by the mean blood glucose level and multiplying by 100. It gives a relative measure of variability, which is helpful in comparing variability between individuals or groups with different mean glucose levels.
15 secondary outcomes
Glycaemic control
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Insulin administred during intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Dysglycemic events during intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Gastrointestinal tolerance during the intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
Gastrointestinal tolerance during the intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Circadian rhythm
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Circadian rhythm
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Body composition
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Muscle size
Time frame: Measured at day 1 and the end of the study period. End of the study period is day 5 of the study or earlier in case of: extubation, patient is no longer exclusively fed by gastric enteral nutrition or patient is discharged from ICU.
Nutritional intake during intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days.
Non-nutritonal calories administred during intervention period
Time frame: From enrollment to the end of the intervention at a maximum of 5 days
Health-related quality of life
Time frame: 60 days after ICU admission
Sleep quality
Time frame: 60 days after ICU admission
Glucoregulatory gastrointestinal hormones
Time frame: From 12:00 until 14:00 on the second study day.
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 13 Mar 2026.
- 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.
Imre WK Kouw contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent enteral nutrition in people with Critical Illness, run by Gelderse Vallei Hospital at 5 sites in Netherlands.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
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 Arthur RH van Zanten (+3131843115, ZantenA@zgv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic variability (time frame: From enrollment to the end of the intervention at a maximum of 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.