NCT02415374已完成不适用
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- iAUC for each AVA
研究概览
简要总结
The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female non-obese subjects (18kg/M2<BMI<28kg/M2)
- •Age 20-45 years)
- •Sign an informed consent form approved by UMN-IRB
- •Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study
排除标准
- •Presence of GI conditions that interfere with absorption;
- •Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
- •Major trauma or surgery within 3 months of visit;
- •Cancer in the prior 2 years;
- •Allergic to oat products;
- •Women who are pregnant or lactating;
- •Drinking alcohol >5 drinks/week;
- •Using nutraceuticals;
- •Blood pressure medication;
- •NSAID (>800 mg ibuprofen/week);
- •Vitamin supplementation;
- •Anticoagulants or hypoglycemic drugs;
- •Oat products consumption the day before the test;
- •Rigorous physical activity the day before the test;
- •Consumption of a high-flavonoid diet in the week prior to the test.
结局指标
主要结局
iAUC for each AVA
时间窗: 0-10 hours
Cmax for each AVA
时间窗: 0-10 hours
Tmax for each AVA
时间窗: 0-10 hours
T1/2 for each AVA
时间窗: 0-10 hours
次要结局
未报告次要终点
研究者
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