Chronobiology and Enteral Nutrition
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.
1 other identifier
interventional
60
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2025
CompletedFirst Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 28, 2026
February 1, 2026
9 months
April 21, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in Hormonal Rhythmicity - melatonin
melatonin measured in pg/ml in saliva
From baselilne to 24 hours
Changes in Hormonal Rhythmicity - cortisol
cortisol measured in µg/dl in saliva
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)
From baselilne to 24 hours
Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment
Assessed via actigraphy and continuous glucose monitoring
From baselilne to 24 hours
Study Arms (3)
Experimental EN: Enteral Nutrition
EXPERIMENTALHospitalised Patients Receiving EN Daytime-restricted EN
Experimental EN: Enteral Nutrition + Melatonin
EXPERIMENTALHospitalised Patients Receiving EN + Melatonin
Control group
PLACEBO COMPARATORHospitalised Patients Receiving EN + Placebo
Interventions
Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).
Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).
Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Pregnancy
- Use of melatonin for sleep.
- Uncontrolled psychiatric condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Regional Universitario de Málaga, FIMABIS
Málaga, Málaga, 29009, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2026
First Posted
April 28, 2026
Study Start
October 10, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
April 28, 2026
Record last verified: 2026-02