The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients
CONVEnIENT
1 other identifier
interventional
124
1 country
5
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
September 15, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 13, 2026
September 1, 2025
2.7 years
August 5, 2025
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From enrollment to the end of the intervention at a maximum of 5 days.
Secondary Outcomes (15)
Glycaemic control
From enrollment to the end of the intervention at a maximum of 5 days
Insulin administred during intervention period
From enrollment to the end of the intervention at a maximum of 5 days
Dysglycemic events during intervention period
From enrollment to the end of the intervention at a maximum of 5 days
Gastrointestinal tolerance during the intervention period
From enrollment to the end of the intervention at a maximum of 5 days.
Gastrointestinal tolerance during the intervention period
From enrollment to the end of the intervention at a maximum of 5 days
- +10 more secondary outcomes
Other Outcomes (2)
ICU length of stay
During index ICU stay, up to 60 days.
Days on mechanical ventilation
During index ICU stay, up to 60 days.
Study Arms (2)
Continuous enteral nutrition
NO INTERVENTIONParticipants will receive the standard of care, continuous enteral nutrition for 24 hours a day.
Intermittent enteral nutrition
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Gelderse Vallei Hospital
Ede, Gelderland, 6716 RP, Netherlands
Deventer Ziekenhuis
Deventer, Overijssel, 7416 SE, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ, Netherlands
Martini Ziekenhuis
Groningen, Provincie Groningen, 9728NT, Netherlands
Haga Ziekenhuis
The Hague, South Holland, 2545 AA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Internist-intensivist, Medical Head of ICU and Research
Study Record Dates
First Submitted
August 5, 2025
First Posted
September 15, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 13, 2026
Record last verified: 2025-09