Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- 1. Area Under the Curve (AUC)
研究概览
简要总结
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.
详细描述
At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the licorice dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the licorice dietary supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy peri- and post-menopausal women ages 40 - 79
- •non-smokers
- •no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
- •no medical condition that requires chronic use of medication
排除标准
- •known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or licorice
- •positive pregnancy test
- •use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
- •use of caffeine products 7 days before study participation or during the study
- •use of citrus products 7 days before study participation or during the study
- •other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
- •chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
- •unwillingness to comply with study requirements
- •current participation in another clinical trial
- •CYP2D6 deficiency based on phenotyping at screening
- •licorice (whether as a botanical dietary supplement, candy, food, drink or otherwise) within the previous two weeks and during the study
- •use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
- •extreme obesity (defined as >40 BMI)
- •alcohol or drug abuse
- •chronic diseases such as diabetes.
研究组 & 干预措施
G.Glabra
single arm
干预措施: Dextromethorphan 30mg (Drug)
G.Glabra
single arm
干预措施: Tolbutamide 250 mg (Drug)
G.Glabra
single arm
干预措施: Licorice (Dietary Supplement)
G.Glabra
single arm
干预措施: Alprazolam 2 MG (Drug)
G.Glabra
single arm
干预措施: Caffeine 100 MG (Drug)
结局指标
主要结局
1. Area Under the Curve (AUC)
时间窗: baseline and 14 days
Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.
次要结局
- 4. Drug Half-life [Time Frame: baseline and 14 days](baseline and 14 days)
- 1. Apparent Clearance(baseline and 14 days)
- 2. Peak Concentration(baseline and 14 days)
- 3. Time for Peak Concentration(baseline and 14 days)
研究者
Richard B van Breemen
Professor
University of Illinois at Chicago