An interventional study of Patient recieving enteral nutrition and Hospitalised Patients Receiving EN: 24-hour EN + Melatonin in Hospitalised Patients With Enteral Nutrition, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
Medical Nutritional Therapy (MNT) is critical for patients with impaired oral intake and is typically administered via enteral nutrition (EN). Current infusion practices-continuous 24-hour enteral nutrition for hospitalised patients-may induce circadian misalignment (chronodisruption). This misalignment can negatively impact metabolic function, sleep quality, and overall quality of life for both patients and caregivers. Synchronising MNT administration with circadian rhythms may improve metabolic balance, sleep, and patient well-being.
Hypothesis: The timing of the administration of Medical Nutritional Therapy via continuous enteral nutrition (EN) in hospitalised patients may induce chronodisruption in biological rhythms (clock genes). This disruption can affect the metabolism of carbohydrates, lipids, and proteins, contributing to morbidity and altering chronotype, quality of life, and sleep patterns.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hospitalised Patients Receiving EN Daytime-restricted EN
Other: Patient recieving enteral nutrition
Hospitalised Patients Receiving EN + Melatonin
Other: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
Hospitalised Patients Receiving EN + Placebo
Other: Control treatment arm
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
Changes in Hormonal Rhythmicity - melatonin
melatonin measured in pg/ml in saliva
Time frame: From baselilne to 24 hours
Changes in Hormonal Rhythmicity - cortisol
cortisol measured in µg/dl in saliva
Time frame: From baselilne to 24 hours
Changes in Circadian Gene Expression
Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
Time frame: From baselilne to 24 hours
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
Time frame: From baselilne to 24 hours
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud