Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Breath limonene value in parts per billion
研究概览
简要总结
The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.
详细描述
Cytochrome P450 2C19 is an important enzyme that metabolizes many drugs. However, individuals with genetic variants of CYP2C19, such as CYP2C19*2 and CYP2C19*3, are poor metabolizers of these drugs. Therefore, it is of interest to determine whether the investigators can develop a non-invasive assay to identify genetic variants of CYP2C19 by using a substrate for CYP2C19 found in citrus fruit, limonene. The purpose of the study is to examine changes in limonene levels in human breath after drinking orange peel extract for people with CYP2C19*2 and CYP2C19*3 genetic variants versus those that do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
We are using quantitative assays for this study which reduce the need for masking of the participant or investigator.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: Greater than 18 years and less than 45 years.
- •Gender: Male or Female
- •Ethnicities: East Asian
排除标准
- •Pregnant and/or Breastfeeding
- •previous allergic reaction to limonene, citrus fruits, bovine gelatin, glycerin
- •past medical history of cerebrovascular or cardiovascular disease
- •history of chest pain or shortness of breath in the past month
- •certain medications that are CYP2C19 substrates or CYP2C19 inhibitors
- •Non-East Asian descent
- •age less than 18 y.o or age greater than 45 y.o
结局指标
主要结局
Breath limonene value in parts per billion
时间窗: 2 hours
The amount of limonene in the breath will be measured by mass spectrometry for each participant.
次要结局
未报告次要终点
研究者
Eric Gross
Assistant Professor
Stanford University