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Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

RecruitingNAAges 18 Years - anyAllFundación Pública Andaluza para la Investigación …
NCT07554703 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Patient recieving home parenteral nutrition
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Where

1 site
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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