RecruitingNot ApplicableNCT07554716

Chronobiology and Enteral Nutrition

Chronobiology and Chronodisruption in People Receiving Medical Nutritional Therapy and Its Impact on the Quality of Life of Patients and Caregivers. A Descriptive and Interventional Study. Chronumet.


Sponsor

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

Enrollment

60 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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).

Exclusion Criteria3

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

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Interventions

OTHERPatient recieving enteral nutrition

Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).

OTHERHospitalised Patients Receiving EN: 24-hour EN + Melatonin

Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).

OTHERControl treatment arm

Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).


Locations(1)

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, Málaga, Spain

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NCT07554716