Patients With Home Parenteral Nutrition
Conditions
Keywords
Chronobiology, Parenteral Nutrition, Biological rhythms
Brief 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.
Interventions
OTHERPatient 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.
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
For Patients Receiving Home Parenteral Nutrition: * Phase 1: Transition from nocturnal to daytime administration of parenteral nutrition for four consecutive days. * Washout Period: A neutral phase with the original nocturnal regimen for 4 consecutive days to prevent carryover effects. * Phase 2: Following the washout period, patients will receive melatonin supplementation (0.5 mg sublingual, nightly) for 4 days while maintaining the adjusted nocturnal infusion schedule.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months. Referred 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 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. * Participants must provide informed consent (patient or legal representative). * Participants must be able to answer the questionnaires. * Participants must be metabolically and clinically stable.
Exclusion criteria
* Known sleep or circadian rhythm disorders. * Use of melatonin for sleep.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment | From baselilne to 24 hours | Assessed via actigraphy and continuous glucose monitoring |
Countries
Spain
Contacts
CONTACTFrancisca Rodríguez, PhD
CONTACTGabrie, MD
Outcome results
None listed