Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test (GEBT) Results
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in vivo 13C-Spirulina GEBT response
研究概览
简要总结
The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).
详细描述
In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% Nitrogen content will be administered. Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling. The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18-85 years old at time of signing consent form
- •Ability to eat test meal and provide breath samples
排除标准
- •History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
- •Symptoms consistent with delayed gastric emptying
- •History of abdominal surgery except appendectomy
- •Use of any medications that may alter gastric motility within two days of the study
- •Use of narcotics or anticholinergics within two days of the study
- •Females on hormone replacement therapy other than birth control medications
- •Receipt of an investigational drug within 4 weeks of the study
- •Pregnancy
- •Intolerance or allergy to any component of Gastric Emptying Breath Test meal
- •History of neurologic or psychiatric disorder
结局指标
主要结局
Difference in vivo 13C-Spirulina GEBT response
时间窗: Up to 2 weeks
Determining the difference between measure gastric emptying rate (kPCD) results produced from the low %N 13C-Spirulina GEBT test meal and the FDA-approved test meal
次要结局
未报告次要终点