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.
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
- 否
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
Hospitalised Patients Receiving EN Daytime-restricted EN
干预措施: Patient recieving enteral nutrition (Other)
Experimental EN: Enteral Nutrition + Melatonin
Hospitalised Patients Receiving EN + Melatonin
干预措施: Hospitalised Patients Receiving EN: 24-hour EN + Melatonin (Other)
Control group
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
