Garlic Metabolism and Cytochrome P450 Modulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood plasma and urine samples
研究概览
简要总结
This study will determine whether garlic supplements affect the way certain drugs are processed in the body.
详细描述
Garlic supplements, which are often used to lower cholesterol and prevent cancer, are one of the most commonly used herbal products in the United States.
However, little is known about the way garlic supplements may interact with prescription medications when used simultaneously. This study will investigate four commonly used garlic supplements: garlic powder with a low content of allicin (a compound with antibacterial properties), garlic powder with a high allicin content, garlic oil, and aged garlic. The effects of these 4 garlic products on the drug-metabolizing enzyme cytochrome P450 (CYP) and a drug transporter, P-glycoprotein (Pgp) will be examined.
Participants will be randomly assigned to receive one of the four garlic supplements for 4 weeks. Drug probes of CYP and Pgp will be used to assess the in vivo activities of the substances. On the first day of garlic ingestion, blood collection will occur immediately after participants ingest their garlic supplement and 3, 4, and 6 hours after ingestion. Urine collection will occur immediately after participants' first garlic ingestion and 12, 15, and 72 hours after ingestion. Blood and urine collection will determine the concentration of the drug probes in the body, which will indicate changes in CYP and Pgp. Blood and urine tests will be repeated at the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Body mass index (BMI) between 20 and 32
- •Able to read and understand English
- •MUST LIVE WITHIN THE SEATTLE, WA AREA.
排除标准
- •Current use of herbal medicines other than oral contraceptives
- •History of cardiopulmonary, liver, renal or endocrine disease
- •Allergy or sensitivity to any of the drugs that will be used in the probe cocktails or the garlic supplements
- •Daily consumption of vegetables with a high allium content, including garlic, shallots, leeks, and chives
- •Pregnancy or breastfeeding
结局指标
主要结局
Blood plasma and urine samples
时间窗: 3 months
次要结局
- Blood plasma and breath samples.(3 months)
