Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT07554716
Recruiting Not applicable

Chronobiology and Enteral Nutrition

NCT07554716 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Phase
Not applicable
Started
2025-10-10
Last updated
2026-04-28

Condition(s) studied

Hospitalised Patients With Enteral Nutrition

Investigational drug(s) / intervention(s)

Patient recieving enteral nutritionHospitalised Patients Receiving EN: 24-hour EN + MelatoninControl treatment arm

Patient recieving enteral nutrition: Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).

Hospitalised Patients Receiving EN: 24-hour EN + Melatonin: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).

Control treatment arm: Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).

Study summary

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 sleep patterns.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Changes in Hormonal Rhythmicity - melatonin — From baselilne to 24 hours
    melatonin measured in pg/ml in saliva
  • Changes in Hormonal Rhythmicity - cortisol — From baselilne to 24 hours
    cortisol measured in µg/dl in saliva
  • Changes in Circadian Gene Expression — From baselilne to 24 hours
    Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
  • Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment — From baselilne to 24 hours
    Assessed via actigraphy and continuous glucose monitoring

Trial sites (1)

FacilityCityRegionStatus
Hospital Regional Universitario de Málaga, FIMABIS Málaga Málaga Recruiting

More Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud trials in Spain

Implementing Online Mental Health Program Starting soon
Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients Recruiting
NIMA-Colon Cancer Study Recruiting
Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study Recruiting
Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554716 on ClinicalTrials.gov ↗ ← All trials in Spain