Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07554716

Chronobiology and Enteral Nutrition

Led by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Updated on 2026-04-28

60

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chronobiology and Enteral Nutrition

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Use of enteral nutrition (EN) for 15 days or more
  • Participants must be from the Regional University Hospital of Málaga, Virgen del Rocío Hospital of Seville, Reina Sofía University Hospital of Córdoba, or the NUPA Association
  • No acute metabolic decompensation in the last 7 days
  • Ability to answer questionnaires with or without family support
  • Provided informed consent (patient or legal representative)
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Use of melatonin for sleep
  • Uncontrolled psychiatric condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Regional Universitario de Málaga, FIMABIS

Málaga, Málaga, Spain, 29009

Actively Recruiting

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Research Team

F

Francisca Rodríguez, PhD

CONTACT

G

Gabriel Olveira Fuster, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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