Chronobiology and Enteral Nutrition

April 21, 2026 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental EN: Enteral Nutrition
Hospitalised Patients Receiving EN Daytime-restricted EN
Other: Patient recieving enteral nutrition
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Experimental: Experimental EN: Enteral Nutrition + Melatonin
Hospitalised Patients Receiving EN + Melatonin
Other: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Placebo Comparator: Control group
Hospitalised Patients Receiving EN + Placebo
Other: Control treatment arm
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Hormonal Rhythmicity - melatonin
Time Frame: From baselilne to 24 hours
melatonin measured in pg/ml in saliva
From baselilne to 24 hours
Changes in Hormonal Rhythmicity - cortisol
Time Frame: From baselilne to 24 hours
cortisol measured in µg/dl in saliva
From baselilne to 24 hours
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)
From baselilne to 24 hours
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Time Frame: From baselilne to 24 hours
Assessed via actigraphy and continuous glucose monitoring
From baselilne to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • "CHRONO-EN" trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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