About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months.
Participants must not have suffered any recent acute illnesses.
Participants must not have been hospitalized, received transfusions, or visited the emergency room in the last month.
Participants must not have made significant changes to their diet or physical activity during the last two months.
Disqualifiers
Known sleep or circadian rhythm disorders.
Use of melatonin for sleep.
Trial design
Single group
Treatments tested in this trial
Patient recieving home parenteral nutrition
Other intervention* 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes in Circadian Gene Expression
Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
Changes in Hormonal Rhythmicity - melatonin
Melatonin measured in pg/ml in saliva
Changes in Hormonal Rhythmicity - cortisol
Cortisol measured in µg/dl in saliva
Secondary outcomes
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
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