Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Route and type of feeding on Immune response
研究概览
简要总结
Literature suggests that route of feeding and/or certain nutrients may cause alterations in the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a small tube. The immune system may respond differently when receiving continuous TF as compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between heartbeats) is a measurement of the nervous system's response to a stress/illness. The differences in immune cells and/or HRV may influence how the body reacts to complications such as infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General good health as demonstrated by medical history, physical& laboratory tests
- •Age between 18 and 40 years
- •Written informed consent prior to the performance of any study related procedures
排除标准
- •History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
- •Any medication taken in past 48 hrs (except birth control)
- •Recent history of alcohol or drug abuse
- •Unable to provide written informed consent
- •Exposure to any experimental agent or procedure within 30 days of study
- •Pregnant or breast-feeding
研究组 & 干预措施
Enteral Continuous
Continuous tube feeding for 72 hours.
干预措施: Enteral Continuous (Dietary Supplement)
Enteral Intermittent
Intermittent tube feedings for 72 hours
干预措施: Enteral Intermittent (Dietary Supplement)
Parenteral
Parenteral continuously for 72 hours
干预措施: Parenteral Continuous (Dietary Supplement)
结局指标
主要结局
Route and type of feeding on Immune response
时间窗: Day 1- Day 4
次要结局
未报告次要终点