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RECRUITING
NCT07554716
NA

Chronobiology and Enteral Nutrition

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

View on ClinicalTrials.gov

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

OTHER

Patient recieving enteral nutrition

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

OTHER

Hospitalised Patients Receiving EN: 24-hour EN + Melatonin

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

OTHER

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