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Recruiting

NCT Number: NCT07554716

Chronobiology and Enteral Nutrition

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.

Recruiting

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Key information

Conditions

Hospitalised Patients With Enteral Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, 29009, Spain

Location status: Recruiting

Location contact

Gabriel Olveira Fuster, MD

CONTACT

[email protected]

951290343/951030117

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient recieving enteral nutrition

Other

Patients Receiving EN Daytime-restricted EN (9 AM to 9 PM for 4 days).

Hospitalised Patients Receiving EN: 24-hour EN + Melatonin

Other

Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (0.5 mg sublingual at 8 PM).

Control treatment arm

Other

Hospitalised Patients Receiving EN: 24-hour EN + Placebo (sublingual at 8 PM).

Primary outcomes

  1. Changes in Hormonal Rhythmicity - melatonin

    Time frame: From baselilne to 24 hours

    melatonin measured in pg/ml in saliva

  2. Changes in Hormonal Rhythmicity - cortisol

    Time frame: From baselilne to 24 hours

    cortisol measured in µg/dl in saliva

  3. 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)

  4. Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment

    Time frame: From baselilne to 24 hours

    Assessed via actigraphy and continuous glucose monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Francisca Rodríguez, PhD

CONTACT

[email protected]

951290343/951030117

Gabriel Olveira Fuster, MD

CONTACT

[email protected]

951290343/951030117

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.