Hospitalised Patients With Enteral Nutrition
Conditions
Keywords
Chronobiology, Enteral Nutrition, Biological rhythms
Brief 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.
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).
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Pregnancy * Use of melatonin for sleep. * Uncontrolled psychiatric condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hormonal Rhythmicity - melatonin | From baselilne to 24 hours | melatonin measured in pg/ml in saliva |
| Changes in Hormonal Rhythmicity - cortisol | From baselilne to 24 hours | cortisol measured in µg/dl in saliva |
| Changes in Circadian Gene Expression | From baselilne to 24 hours | Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples) |
| Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment | From baselilne to 24 hours | Assessed via actigraphy and continuous glucose monitoring |
Countries
Spain
Contacts
CONTACTFrancisca Rodríguez, PhD
CONTACTGabriel Olveira Fuster, MD
Outcome results
None listed