Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Patient recieving home parenteral nutrition: * 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.

Study summary

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

Primary outcome measure(s)

• Changes in Circadian Gene Expression — From baselilne to 24 hours for 4 days
  Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
• Changes in Hormonal Rhythmicity - melatonin — From baselilne to 24 hours for 4 days
  Melatonin measured in pg/ml in saliva
• Changes in Hormonal Rhythmicity - cortisol — From baselilne to 24 hours for 4 days
  Cortisol measured in µg/dl in saliva

Trial sites (1)

More Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials in Spain