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NCT Number: NCT07173504

The Effect of Continuous Versus Intermittent Enteral Nutrition on Metabolic Outcomes in Critically Ill Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gelderse Vallei Hospital, Ede, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intermittent Enteral Nutrition

Other

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.

Other names: Intermittent tube feeding

Primary outcomes

  1. 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.

Secondary outcomes

  1. Glycaemic control

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days

    Assessed by mean and standard deviation of interstitial glucose concentrations and Mean Amplitude of Glycaemic Excursions (MAGE) (mmol/L)

  2. Insulin administred during intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days

    Insulin administred during intervention period (IU/day)

  3. Dysglycemic events during intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days

    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

  4. Gastrointestinal tolerance during the intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days.

    Gastric residual volumes (mL), minimum, maximum and total volume per 24 hours.

  5. Gastrointestinal tolerance during the intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days

    Incidence of vomiting, diarrhoea, constipation and regurgitation during the intervetion periode

  6. 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.

    Assessed by 24-hour curves of melatonin ( pg/mL) in saliva.

  7. 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.

    Assessed by 24-hour curves of cortisol( nmol/L) in saliva.

  8. 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.

    Assessed by 24-hour curves of mRNA expression of essential clock genes (BMAL, CLOCK, Cry1 and Per2).

  9. 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.

    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.

  10. 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.

    Cross-sectional area and muscle layer thickness of quadriceps muscle by ultrasonography. This outcome is only measured in centres with the necessary equipment.

  11. Nutritional intake during intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days.

    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)

  12. Non-nutritonal calories administred during intervention period

    Time frame: From enrollment to the end of the intervention at a maximum of 5 days

    Non-nutritional calories delivered by propofol, glucose infusion, and citrate, delivery in kJ per calendar day

  13. Health-related quality of life

    Time frame: 60 days after ICU admission

    Health-related quality of life measured with the 36-Item Short Form Health Survey (SF-36), 60 days after ICU admission

  14. Sleep quality

    Time frame: 60 days after ICU admission

    Sleep quality measured with the Pittsburgh Sleep Quality Index (PSQI)

  15. Glucoregulatory gastrointestinal hormones

    Time frame: From 12:00 until 14:00 on the second study day.

    GLP-1, C-peptide, insulin, and glucagon concentrations (mmol/L). This outcome is only measured in the coordinating centre.

Other outcomes

  1. ICU length of stay

    Time frame: During index ICU stay, up to 60 days.

    ICU length of stay

  2. Days on mechanical ventilation

    Time frame: During index ICU stay, up to 60 days.

    Days on mechanical ventilation

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur RH van Zanten

CONTACT

[email protected]

+3131843115

Imre WK Kouw

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Gelderse Vallei Hospital

Other

Collaborators

  • Wageningen University and Research
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: CONVEnIENT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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