Medical Nutritional Therapy (MNT) is critical for patients with impaired oral intake and is typically administered via parenteral nutrition (PN). Current infusion practices-nocturnal home parenteral nutrition (NHPN)-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 nocturnal home parenteral nutrition (NHPN) in outpatients 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
* Transition from nocturnal PN to daytime PN (9 AM to 9 PM) for 4 consecutive days. * A four-day washout period where the nocturnal PN (9PM to 9AM) regimen is reinstated. * A final 4-day phase where melatonin supplementation (0.5 mg sublingual drops at 8 PM) is introduced while maintaining nocturnal PN.
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, Spain
RECRUITINGChanges 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 hours for 4 days
Changes in Hormonal Rhythmicity - melatonin
Melatonin measured in pg/ml in saliva
Time frame: From baselilne to 24 hours for 4 days
Changes in Hormonal Rhythmicity - cortisol
Cortisol measured in µg/dl in saliva
Time frame: From baselilne to 24 hours for 4 days
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
Time frame: From baselilne to 24 hours
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