Chronobiology and Enteral Nutrition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient recieving enteral nutrition, Hospitalised Patients Receiving EN: 24-hour EN + Melatonin, Control treatment arm.
- Who it may be relevant to
- Registry conditions: Hospitalised Patients With Enteral Nutrition. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Other Patient recieving enteral nutrition
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days). - Other Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM). - Other Control treatment arm
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
Primary outcome measures
- Changes in Hormonal Rhythmicity - melatonin [Time frame: From baselilne to 24 hours]
- Changes in Hormonal Rhythmicity - cortisol [Time frame: From baselilne to 24 hours]
- Changes in Circadian Gene Expression [Time frame: From baselilne to 24 hours]
- Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment [Time frame: From baselilne to 24 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Regional Universitario de Málaga, FIMABIS — Málaga
Identifiers
NCT: NCT07554716 · "CHRONO-EN" trial