Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study

Официальное название

Chronobiology and Chronodisruption in People Receiving Medical Nutritional Therapy and Its Impact on the Quality of Life of Patients and Caregivers. A Descriptive and Interventional Study. Chronumet.

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Changes in Circadian Gene Expression [Срок оценки: From baselilne to 24 hours for 4 days]
• Changes in Hormonal Rhythmicity - melatonin [Срок оценки: From baselilne to 24 hours for 4 days]
• Changes in Hormonal Rhythmicity - cortisol [Срок оценки: From baselilne to 24 hours for 4 days]

Вторичные конечные точки (1)

• Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment [Срок оценки: From baselilne to 24 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Known sleep or circadian rhythm disorders.
• Use of melatonin for sleep.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Regional Universitario de Málaga, FIMABIS — Málaga

Идентификаторы

NCT: NCT07554703 · CHRONO-HPN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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