[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635594":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":39,"locations":48,"responsibleParty":64,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":30,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental EN: Enteral Nutrition","EXPERIMENTAL","Hospitalised Patients Receiving EN Daytime-restricted EN",[13],"Other: Patient recieving enteral nutrition",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental EN: Enteral Nutrition + Melatonin","Hospitalised Patients Receiving EN + Melatonin",[18],"Other: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","PLACEBO_COMPARATOR","Hospitalised Patients Receiving EN + Placebo",[24],"Other: Control treatment arm",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Patient recieving enteral nutrition","Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).",[9],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Hospitalised Patients Receiving EN: 24-hour EN + Melatonin","Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Control treatment arm","Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).",[20],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Francisca Rodríguez, PhD","CONTACT","951290343\u002F951030117","paqui.endocrino@gmail.com",{"name":46,"role":42,"phone":43,"phoneExt":30,"email":47},"Gabriel Olveira Fuster, MD","gabrielm.olveira.sspa@juntadeandalucia.es",[49],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital Regional Universitario de Málaga, FIMABIS","RECRUITING","Málaga","29009","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-4.42034,36.72016,{"lat":60,"lon":59},[63],{"name":46,"role":42,"phone":43,"phoneExt":30,"email":47},{"type":65,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100635594","chronobiology-and-enteral-nutrition-100635594",false,"NCT07554716","Chronobiology and Enteral Nutrition","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.","Inclusion Criteria:\n\n* 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.\n* Participants must not have experienced acute metabolic decompensation in the last 7 days.\n* Participants must be able to answer the questionnaires with or without family support.\n* Participants must provide informed consent (patient or legal representative).\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of melatonin for sleep.\n* Uncontrolled psychiatric condition.","ALL","18 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nHypothesis: 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 sleep patterns.",[83],"Hospitalised Patients With Enteral Nutrition",[85,86,87],"Chronobiology","Enteral Nutrition","Biological rhythms","2026-04-21",{"date":90,"type":91},"2026-04-28","ACTUAL",{"date":93,"type":91},"2025-10-10",{"date":95,"type":77},"2027-12-31",{"name":5,"class":6},1]