Hospitalised Patients With Enteral NutritionNCT07554716
Chronobiology and Enteral Nutrition
A study testing Patient recieving enteral nutrition and Hospitalised Patients Receiving EN: 24-hour EN + Melatonin in people with Hospitalised Patients With Enteral Nutrition, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalised Patients With Enteral Nutrition
- What is being tested?
- Patient recieving enteral nutrition and Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Pregnancy
- Use of melatonin for sleep.
- Uncontrolled psychiatric condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, 29009
Gabriel Olveira Fuster, MD, 951290343/951030117, gabrielm.olveira.sspa@juntadeandalucia.es
About this study
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.
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.
- Being tested
- Patient recieving enteral nutrition, Hospitalised Patients Receiving EN: 24-hour EN + Melatonin, Control treatment arm
- Keywords
- Chronobiology, Enteral Nutrition, Biological rhythms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient recieving enteral nutritionOther
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Hospitalised Patients Receiving EN: 24-hour EN + MelatoninOther
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Control treatment armOther
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
| Study group | Role | What they receive |
|---|---|---|
| Experimental EN: Enteral Nutrition | Experimental | Hospitalised Patients Receiving EN Daytime-restricted EN Receives: Other: Patient recieving enteral nutrition |
| Experimental EN: Enteral Nutrition + Melatonin | Experimental | Hospitalised Patients Receiving EN + Melatonin Receives: Other: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin |
| Control group | Placebo comparator | Hospitalised Patients Receiving EN + Placebo Receives: Other: Control treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hormonal Rhythmicity - melatonin
melatonin measured in pg/ml in saliva
Measured: From baselilne to 24 hours
Changes in Hormonal Rhythmicity - cortisol
cortisol measured in µg/dl in saliva
Measured: From baselilne to 24 hours
Changes in Circadian Gene Expression
Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
Measured: From baselilne to 24 hours
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
Measured: From baselilne to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start10 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalised Patients With Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554716
- Sponsor's protocol ID
- "CHRONO-EN" trial
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07554716
- Acronym / sponsor ID
- "CHRONO-EN" trial
- Keywords
- Chronobiology, Enteral Nutrition, Biological rhythms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental EN: Enteral Nutrition | Experimental | Other: Patient recieving enteral nutritionHospitalised Patients Receiving EN Daytime-restricted EN |
| Experimental EN: Enteral Nutrition + Melatonin | Experimental | Other: Hospitalised Patients Receiving EN: 24-hour EN + MelatoninHospitalised Patients Receiving EN + Melatonin |
| Control group | Placebo comparator | Other: Control treatment armHospitalised Patients Receiving EN + Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Pregnancy
- Use of melatonin for sleep.
- Uncontrolled psychiatric condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient recieving enteral nutritionPatients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days). | Other | Experimental EN: Enteral Nutrition |
| Hospitalised Patients Receiving EN: 24-hour EN + MelatoninHospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM). | Other | Experimental EN: Enteral Nutrition + Melatonin |
| Control treatment armHospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM). | Other | Control group |
Primary outcome
Changes in Hormonal Rhythmicity - melatonin
Time frame: From baselilne to 24 hours
melatonin measured in pg/ml in saliva
Changes in Hormonal Rhythmicity - cortisol
Time frame: From baselilne to 24 hours
cortisol measured in µg/dl in saliva
Changes in Circadian Gene Expression
Time frame: 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
Time frame: From baselilne to 24 hours
Assessed via actigraphy and continuous glucose monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient recieving enteral nutrition and Hospitalised Patients Receiving EN: 24-hour EN + Melatonin in people with Hospitalised Patients With Enteral Nutrition, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisca Rodríguez, PhD (951290343/951030117, paqui.endocrino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hormonal Rhythmicity - melatonin (time frame: From baselilne to 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.