An interventional study of Cyclic daytime enteral nutrition in Critical Illness, Intensive Care Unit and Circadian Rhythm, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Treatment
Disruption of circadian rhythms is frequently observed in patients in the intensive care unit (ICU) and is associated with worse clinical outcomes. The ICU environment presents weak and conflicting timing cues to the circadian clock, including continuous enteral nutrition. The goal of this clinical trial is to evaluate the effect of timing of enteral nutrition on the circadian rhythm in critically ill patients. Patients admitted to the intensive care unit will be allocated to receive either continuous or cyclic daytime (8am to 8 pm) enteral feeding. Differences in circadian rhythms will be assessed by 24h patterns in core body temperature, heart rate variability, melatonin and peripheral clock gene expression. Secondary outcomes include depth of sleep, glucose variability and incidence of feeding intolerance. This study is expected to contribute to the optimalisation of circadian rhythms in the ICU.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
continuous enteral nutrition: 24 hours a day (standard of care)
cyclic daytime enteral nutrition: between 8 a.m. and 8 p.m. (same amount of nutrition as control group)
Other: Cyclic daytime enteral nutrition
The allocated feeding schedule is followed from the start of enteral nutrition after ICU admission until discharge from the ICU.
Amplitude of 24-h rhythm of core body temperature
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Acrophase 24-h rhythm of core body temperature
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Amplitude of 24-h rhythm of plasma melatonin levels
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Acrophase of 24-h rhythm of plasma melatonin levels
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Amplitude of 24-h rhythm in heart rate variability
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Acrophase of 24-h rhythm in heart rate variability
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Amplitude of 24-h rhythm in systolic blood pressure
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Acrophase of 24-h rhythm in systolic blood pressure
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Amplitude of 24-h rhythm in heart rate
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Acrophase of 24-h rhythm in heart rate
Determined by cosinor analysis
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Peripheral clock gene expression
Time of day-dependent difference in clock gene expression in PBMCs isolated from blood samples collected at 12 p.m. and 12 a.m.
Time frame: Day 3 (12 p.m.) to day 4 (12 a.m.) after start of the study intervention (= start of enteral nutrition)
Depth of sleep
Daytime (8 a.m. to 8 p.m.) to nighttime (8 p.m. to 8 a.m.) ratio of gamma to delta spectral power ratio in EEG measured with a sleep headband
Time frame: Day 3 (8 a.m.) to day 4 (8 a.m.) after start of the study intervention (= start of enteral nutrition)
Mean daily rate of hyperglycaemia/hypoglycaemia
Hypoglycaemia is defined as glucose levels \< 3.5 mmol/L, hyperglycaemia is defined as glucose levels \>10 mmol/L
Time frame: From start of study intervention (enteral nutrition) to end of study intervention
Mean daily glucose variability
Mean of standard deviation of glucose levels per day
Time frame: From start of study intervention (enteral nutrition) to end of study intervention
Mean daily insulin administration
Mean of number of insulin units used per day
Time frame: From start of study intervention (enteral nutrition) to end of study intervention
Mean daily caloric intake
Mean of percentage of recommended calories that patient receives per day of interest during study period
Time frame: From start of study intervention (enteral nutrition) to end of study intervention
Daily rates of gastric retention
Gastric retention is defined as gastric residual volume \> 200 mL
Time frame: From start of study intervention (enteral nutrition) to end of study intervention
28-day mortality
28-day mortality
Time frame: Up to 28 days
Days on mechanical ventilation
Days on mechanical ventilation
Time frame: From ICU admission to ICU discharge
ICU length of stay
ICU length of stay
Time frame: From ICU admission to ICU discharge
Plan to share: Yes — Immediately following publication, the individual participant data that underlie the results reported in the published article will be shared after deidentificiation. The data will be shared upon request with researchers who wish to access the data for any purpose.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center