Timing of enteral nutrition and body clocks in hospitalized patients
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Academic / other |
| Locations | 1 site (Málaga, Málaga) |
| Trial ID | NCT07554716 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Málaga, Málaga
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.