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临床试验/NCT00122889
NCT00122889已完成不适用

Garlic Metabolism and Cytochrome P450 Modulation

Fred Hutchinson Cancer Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年7月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (1)

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