Chronobiology and Enteral Nutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Pregnancy
Use of melatonin for sleep.
Uncontrolled psychiatric condition.
Trial design
Design model
Parallel
Treatments tested in this trial
Patient recieving enteral nutrition
Other interventionPatients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
Other interventionHospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Control treatment arm
Other interventionHospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Experimental EN: Enteral NutritionExperimental treatment 1 intervention
Group B: Experimental EN: Enteral Nutrition + MelatoninExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Hormonal Rhythmicity - melatonin
melatonin measured in pg/ml in saliva
Time frame
From baselilne to 24 hours2
Changes in Hormonal Rhythmicity - cortisol
cortisol measured in µg/dl in saliva
Time frame
From baselilne to 24 hours3
Changes in Circadian Gene Expression
Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
Time frame
From baselilne to 24 hours4
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
Time frame
From baselilne to 24 hoursSponsors and contacts
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Source ClinicalTrials.gov