Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- LDL
研究概览
简要总结
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.
详细描述
Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
- •Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory
排除标准
- •Patients with significant hepatic, renal or gastrointestinal tract disease
- •Receiving thiazolidinediones or fibric acid derivatives
- •Current overt cardiovascular disease
- •Women of reproductive potential not receiving birth control
- •Pregnant/nursing women
研究组 & 干预措施
High Dose
Pterostilbene 125 mg twice daily
干预措施: Pterostilbene 125 mg twice daily (Drug)
Low Dose
Pterostilbene 50 mg twice daily
干预措施: Pterostilbene 50 mg twice daily (Drug)
Low Dose Combination
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
干预措施: Pterostilbene 50 mg twice daily (Drug)
Low Dose Combination
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
干预措施: Grape Extract (Drug)
Placebo
Matching placebo twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
LDL
时间窗: Baseline and 6-8 weeks
Increase in low density lipoprotein (LDL)
次要结局
- Subjective Adverse Effects(Baseline and 6-8 weeks)
- Blood Pressure(6-8 weeks)
研究者
Daniel Riche
Assistant Professor of Pharmacy Practice and Medicine
University of Mississippi Medical Center