Chronobiology and Enteral Nutrition

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hospitalised Patients With Enteral Nutrition

In brief

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.

Key facts

Study ID

NCT07554716

Run by

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

People needed

60

Starts

2025-10-10

Expected to finish

2027-12-31

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Use of enteral nutrition (EN) for 15 days or more. Participants must be from the Regional University Hospital of Málaga (HRUM), Virgen del Rocío Hospital of Seville (HVR), Reina Sofía University Hospital of Córdoba, or the NUPA Association.
• Participants must not have experienced acute metabolic decompensation in the last 7 days.
• Participants must be able to answer the questionnaires with or without family support.
• Participants must provide informed consent (patient or legal representative).

You may not qualify if…

• Pregnancy
• Use of melatonin for sleep.
• Uncontrolled psychiatric condition.

Where it is running

• Hospital Regional Universitario de Málaga, FIMABIS — Málaga, Málaga, Spain (enrolling)

Full record on ClinicalTrials.gov

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