Timing of enteral nutrition and body clocks in hospitalized patients
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.
Run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · NCT07554716 · Data updated 2026-11-12
This trial will test whether giving melatonin and timing tube feeding to match patients' body clocks helps metabolism, sleep, and quality of life for hospitalized patients on enteral nutrition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Málaga) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07554716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are hospitalized adults on enteral nutrition for 15 days or more at the participating Spanish centers who can provide informed consent and complete questionnaires with or without family help.
✕Probably not a fit
Patients already taking melatonin, pregnant patients, those with uncontrolled psychiatric conditions, or those with recent acute metabolic decompensation are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Hospitalized patients who have received enteral nutrition for at least 15 days are compared between a control arm with standard continuous 24-hour feeding and an intervention arm that pairs timed nutrition with nightly melatonin. The protocol measures biological clock gene markers, metabolic parameters (carbohydrates, lipids, proteins), sleep quality, chronotype, and patient-reported quality of life. Participants must be able to provide informed consent (or have a legal representative) and complete questionnaires with or without family support. The aim is to determine whether synchronizing medical nutritional therapy with circadian rhythms reduces chronodisruption and related morbidity.
Why it matters
Potential benefit: If successful, aligning feeding times and using melatonin could improve metabolic control, sleep, and overall well-being for patients on long-term enteral nutrition.
How similar studies have gone: Small studies of melatonin and circadian-targeted interventions have shown improvements in sleep and some metabolic markers, but synchronizing enteral nutrition timing is a relatively novel approach with limited prior clinical trial data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, Spain Recruiting
Study contacts
- Study coordinator: Francisca Rodríguez, PhD
- Email: paqui.endocrino@gmail.com
- Phone: 951290343/951030117
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Stepwise enteral feeding plan to improve nutrition for critically ill children in the PICU.
This will try a step-by-step tube-feeding plan to see if it helps critically ill infants and children in the pediatric ICU get the nutrition they need.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.