PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Highly sensitive C-reactive protein (hs-CRP)
研究概览
简要总结
The purpose of the study is to establish the pharmacokinetic parameters of cherry juice concentrate and identify its potential to alter inflammatory markers in gout patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gout
排除标准
- •Allergy to cherries or cherry products
- •Any history of malignancy
- •History of any pancreatic or biliary tract disease
- •Significant Anemia
- •History of significant renal (sCr > 1.5 mg/dL)
- •Hepatic disease (liver enzymes 3 times upper limit of normal)
- •Any active gastrointestinal condition
- •History of large bowel resection for any reason
- •Use of cherry juice concentrate or consumption of cherries within 14 days
- •Personal or inherited bleeding disorders or currently on anticoagulation
- •Women of childbearing age not on oral contraceptives
- •Women who are pregnant or nursing
研究组 & 干预措施
Tart cherry concentrate 120 mL
Subjects will receive a single oral dose of 120 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 60 mL dose group.
干预措施: Tart cherry extract 120 mL (Dietary Supplement)
Tart cherry concentrate 60 mL
Subjects will receive a single oral dose of 60 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 120 mL dose group.
干预措施: Tart cherry extract 60 mL (Dietary Supplement)
Tart cherry concentrate 60 mL
Subjects will receive a single oral dose of 60 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 120 mL dose group.
干预措施: Tart cherry extract 120 mL (Dietary Supplement)
Tart cherry concentrate 120 mL
Subjects will receive a single oral dose of 120 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 60 mL dose group.
干预措施: Tart cherry extract 60 mL (Dietary Supplement)
结局指标
主要结局
Highly sensitive C-reactive protein (hs-CRP)
时间窗: Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose)
Reduction in hs-CRP
次要结局
- Peak plasma concentration (Cmax)(Through study completion (during the 12 hours after a dose))
- Time to peak plasma concentration (Tmax)(Through study completion (during the 12 hours after a dose))
- Change in inflammatory marker expression(Through study completion (during the 12 hours after a dose))
- Half-life (t1/2)(Through study completion (during the 12 hours after a dose))
- Area under the curve (AUC)(Through study completion (during the 12 hours after a dose))
研究者
Naomi Schlesinger, MD, Professor of Medicine
Professor of Medicine
Rutgers, The State University of New Jersey