Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES) Among Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of gastric emptying rates
研究概览
简要总结
This crossover study is designed to compare the rates of gastric emptying between two diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott Vital®. Healthy participants will be recruited and randomly assigned into either groups of Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be calculated using established algorithms.
详细描述
The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare because the food needs to be cooked first and it will take time to prepare. Besides, the egg-white sandwich is not suitable for those with allergies to egg and bread and also to vegetarian patients. This gold-standard meal is also not a common meal for Asian people so some of the people may not tolerate with the meal. The aim of this study is to determine whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the gastric meal retention of both meals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal body mass index (BMI)
- •Able to give consent
- •18 years old above
排除标准
- •Vegetarian
- •Allergy or cannot tolerate with milk, egg, and bread
- •Participants with past and current history of chronic medical illness
- •Currently on medication that can affect gastrointestinal function are also excluded
结局指标
主要结局
Change of gastric emptying rates
时间窗: 4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)
Percentage of gastric meal retention (GMR; %)
次要结局
- Symptoms and satiety/satiation(4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour))
- Half-emptying time and slope(T1/2)
研究者
Izleen Laili Binti Ibrahim
Principal Investigator
Universiti Sains Malaysia