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
- 20
- 试验地点
- 1
- 主要终点
- Changes in Circadian Gene Expression
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 parenteral nutrition (PN). Current infusion practices-nocturnal home parenteral nutrition (NHPN)-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 nocturnal home parenteral nutrition (NHPN) in outpatients 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
- Na
- 干预模型
- Single Group
- 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
- •Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months.
- •Referred 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 suffered any recent acute illnesses.
- •Participants must not have been hospitalized, received transfusions, or visited the emergency room in the last month.
- •Participants must not have made significant changes to their diet or physical activity during the last two months.
- •Participants must provide informed consent (patient or legal representative).
- •Participants must be able to answer the questionnaires.
- •Participants must be metabolically and clinically stable.
排除标准
- •Known sleep or circadian rhythm disorders.
- •Use of melatonin for sleep.
研究组 & 干预措施
Experimental HPN: Parenteral Nutrition
干预措施: Patient recieving home parenteral nutrition (Other)
结局指标
主要结局
Changes in Circadian Gene Expression
时间窗: From baselilne to 24 hours for 4 days
Measurement of mRNA expression levels of clock genes (via RT-PCR from oral mucosa samples)
Changes in Hormonal Rhythmicity - melatonin
时间窗: From baselilne to 24 hours for 4 days
Melatonin measured in pg/ml in saliva
Changes in Hormonal Rhythmicity - cortisol
时间窗: From baselilne to 24 hours for 4 days
Cortisol measured in µg/dl in saliva
次要结局
- Changes in Sleep-Wake Cycle and Circadian Rhythm Alignment(From baselilne to 24 hours)