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Chronobiology and Enteral Nutrition
Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-10
Completion Date
2027-12-31
Last Updated
2026-04-28
Healthy Volunteers
No
Interventions
Patient recieving enteral nutrition
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Control 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