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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental EN: Enteral Nutrition | Experimental | Hospitalised Patients Receiving EN Daytime-restricted EN |
|
| Experimental EN: Enteral Nutrition + Melatonin | Experimental | Hospitalised Patients Receiving EN + Melatonin |
|
| Control group | Placebo Comparator | Hospitalised Patients Receiving EN + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient recieving enteral nutrition | Other | Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hormonal Rhythmicity - melatonin | melatonin measured in pg/ml in saliva | From baselilne to 24 hours |
| Changes in Hormonal Rhythmicity - cortisol | cortisol measured in µg/dl in saliva | From baselilne to 24 hours |
| Changes in Circadian Gene Expression | Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples) | From baselilne to 24 hours |
| Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment | Assessed via actigraphy and continuous glucose monitoring | From baselilne to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisca Rodríguez, PhD | Contact | 951290343/951030117 | paqui.endocrino@gmail.com | |
| Gabriel Olveira Fuster, MD | Contact | 951290343/951030117 | gabrielm.olveira.sspa@juntadeandalucia.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario de Málaga, FIMABIS | Recruiting | Málaga | Málaga | 29009 | Spain |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Hospitalised Patients Receiving EN: 24-hour EN + Melatonin | Other | Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM). |
|
| Control treatment arm | Other | Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM). |
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |