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Chronobiology and Enteral Nutrition

RecruitingNAAges 18 Years - anyAllFundación Pública Andaluza para la Investigación …
NCT07554716 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 enteral nutrition (EN). Current infusion practices-continuous 24-hour enteral nutrition for hospitalised patients-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 continuous enteral nutrition (EN) in hospitalised patients 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Use of enteral nutrition (EN) for 15 days or more. Participants must be 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 experienced acute metabolic decompensation in the last 7 days. * Participants must be able to answer the questionnaires with or without family support. * Participants must provide informed consent (patient or legal representative). Exclusion Criteria: * Pregnancy * Use of melatonin for sleep. * Uncontrolled psychiatric condition.
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What it tests

  • Patient recieving enteral nutrition
  • Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
  • Control treatment arm
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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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