The Effect of Intermittent Feeding on Circadian Rhythm in Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- BMAL1 mRNA Expression Level
研究概览
简要总结
The goal of this clinical trial is to determine whether intermittent enteral feeding positively influences circadian rhythms in critically ill patients in intensive care units (ICUs). The main research questions are:
- Does intermittent feeding improve circadian rhythms in ICU patients?
- How does intermittent feeding affect metabolic markers and recovery outcomes? Researchers will compare intermittent feeding to continuous feeding, the current standard method, to assess its impact on circadian stability and patient health.
Participants will:
- Receive intermittent enteral feeding or continuous enteral feeding for at least 10 days
- Undergo blood sample collection at three time points daily (morning, afternoon, midnight) to analyze circadian gene expression and metabolic markers
- Have their clinical condition, nutrition status, and recovery progress monitored throughout the study
详细描述
Circadian rhythms regulate various physiological processes over a 24-hour cycle, including sleep-wake patterns, digestion, blood pressure, and hormone secretion. These rhythms are primarily controlled by the suprachiasmatic nucleus in the hypothalamus and influenced by environmental cues (zeitgebers), such as light exposure and meal timing. Critically ill patients often experience circadian rhythm disruptions due to prolonged artificial lighting, sleep disturbances, and continuous feeding, which may negatively impact metabolic health, immune function, and recovery. Given the significance of meal timing in circadian regulation, intermittent feeding might serve as a therapeutic strategy to restore circadian balance in ICU patients.
This study is a prospective, randomized controlled trial and will be conducted at Ankara Training and Research Hospital's Anesthesia Intensive Care Unit. Ethical approval for the study has been obtained from Ankara Training and Research Hospital with decision number E-93471371-514.99-226714167.
Patients will be randomly assigned to one of two groups:
- Intermittent Feeding Group - enteral nutrition will be provided at scheduled intervals (4-6 times daily) for 20-60 minutes per session, aligning with circadian cycles. Light exposure will also be adjusted, ensuring darkness during night hours.
- Continuous Feeding Group - patients will receive standard continuous enteral nutrition, without specific adjustments for circadian rhythms.
Blood samples will be collected on Day 1 and Day 7 at 08:00, 16:00, and 00:00 to analyze Brain and muscle aryl hydrocarbon receptor nuclear antigen-1 (BMAL1), Cyrptochrome 1 (CRY1), and Period 2 (PER2) gene expression and biochemical markers. No invasive procedures will be performed beyond routine ICU care. Patients' medical history, nutritional status, and clinical parameters will be recorded by using Acute Physiology and Chronic Health Evaluation II (APACHE II) Score, Sequential Organ Failure Assessment (SOFA) Score, Nutrition Risk in Critically ill (NUTRIC) Score and Global Leadership Initiative on Malnutrition (GLIM) Criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •ICU admission for enteral feeding via a gastric tube
- •Expected ≥10 days of enteral nutrition
- •Age ≥18 years
排除标准
- •Age <18 years
- •Pregnancy
- •Gastrointestinal surgery or diseases
- •Tolerance issues with enteral feeding
- •Parenteral feeding requirement
研究组 & 干预措施
Intermittent Feeding Group
Patients receive enteral nutrition at scheduled intervals to align with circadian rhythms.
干预措施: Intermittent feeding (Other)
Continuous Feeding Group
Patients receive enteral nutrition continuously, following the standard ICU practice.
干预措施: Continuous feeding (Other)
结局指标
主要结局
BMAL1 mRNA Expression Level
时间窗: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, BMAL1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
CRY1 mRNA Expression Level
时间窗: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, CRY1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
PER2 mRNA Expression Level
时间窗: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, PER2 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
次要结局
- Lactate Level(From randomization to Day 7)
- C-reactive protein (CRP)(From randomization to Day 7)
- Creatinine Level(From randomization to Day 7)
- Neutrophil Count(From randomization to Day 7)
- Aspartate aminotransferase (AST) Levels(From randomization to Day 7)
- Fasting Glucose Level(From randomization to Day 7)
- Lymphocyte Count(From randomization to Day 7)
- Hemoglobin Level(From randomization to Day 7)
- Platelet Count(From randomization to Day 7)
- Bicarbonate Level(From randomization to Day 7)
- Gamma glutamyl transferase (GGT) Levels(From randomization to Day 7)
- Sodium Levels(From randomization to Day 7)
- White Blood Cell (WBC) Count(From randomization to Day 7)
- Alanine aminotransferase (ALT) Levels(From randomization to Day 7)
- Potassium Levels(From randomization to Day 7)
- Blood Urea Nitrogen (BUN) Levels(From randomization to Day 7)
- Acute Physiology and Chronic Health Evaluation II (APACHE-II) Score(First day of admission to the ICU)
- Sequential Organ Failure Assessment (SOFA) Score(First day of admission to the ICU)
- Nutrition Risk in Critically ill (NUTRIC) Score(First day of admission to the ICU)
- Global Leadership Initiative on Malnutrition (GLIM) Criteria(First day of admission to the ICU)