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临床试验/NCT07554716
NCT07554716招募中不适用

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.

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Changes in Hormonal Rhythmicity - melatonin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

Experimental EN: Enteral Nutrition

Experimental

Hospitalised Patients Receiving EN Daytime-restricted EN

干预措施: Patient recieving enteral nutrition (Other)

Experimental EN: Enteral Nutrition + Melatonin

Experimental

Hospitalised Patients Receiving EN + Melatonin

干预措施: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (Other)

Control group

Placebo Comparator

Hospitalised Patients Receiving EN + Placebo

干预措施: Control treatment arm (Other)

结局指标

主要结局

Changes in Hormonal Rhythmicity - melatonin

时间窗: From baselilne to 24 hours

melatonin measured in pg/ml in saliva

Changes in Hormonal Rhythmicity - cortisol

时间窗: From baselilne to 24 hours

cortisol measured in µg/dl in saliva

Changes in Circadian Gene Expression

时间窗: 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

时间窗: From baselilne to 24 hours

Assessed via actigraphy and continuous glucose monitoring

次要结局

未报告次要终点

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
申办方类型
Other
责任方
Sponsor

研究点 (1)

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