Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying in Healthy Subjects and Bedridden Gastrostomy-fed Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Gastric emptying
研究概览
简要总结
The purpose of this study is to compare the effect of either elemental liquid diet or standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients receiving gastrostomy feeding.
详细描述
A randomized, crossover trial using elemental liquid diet or standard semi-solid diet containing 13C sodium acetate as a tracer is performed in both healthy subjects and bedridden gastrostomy-fed patients. 13C breath tests is performed to estimate gastric emptying.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects bedridden gastrostomy-fed patients
排除标准
- •regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.
研究组 & 干预措施
Elemental liquid diet
Elemental liquid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and healthy subjects drink it within 5 min.
Elemental liquid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and is administered within 15 min using the gastrostomy tube.
干预措施: Elemental liquid diet (Other)
Standard semi-solid diet
Standard semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and healthy subjects drink it within 5 min.
Standard semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and is administered within 15 min using the gastrostomy tube.
干预措施: Standard semi-solid diet (Other)
结局指标
主要结局
Gastric emptying
时间窗: 4 hours
10% 30% or 50% gastric emptying (excretion) time
次要结局
未报告次要终点
研究者
Akira Horiuchi
Chief
Showa Inan General Hospital