Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- OX-LDL
研究概览
简要总结
Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. A large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. In another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human model study designed to evaluate the effect of a standardized formulation of a GSEP (leucoselect-phytosome [LP]) on the susceptibility of LDL to oxidation in a group of heavy smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. Based on these observations, the investigators decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Triglyceride > 150 mg/dl
- •Total Cholesterol > 200 mg/dl
排除标准
- •Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl)
- •Usage of antilipid drugs
- •Herbivore Diet
- •Heart failure
- •Known cases of any malignancy
- •BMI > 30 kg/M2
- •Chronic Hepatic Diseases
- •Chronic Renal Failure
研究组 & 干预措施
Grape Seed Extract
Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
干预措施: Grape Seed Extract (Vitagrape) (Drug)
Placebo
Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
干预措施: Placebo of Grape Seed Extract (Drug)
结局指标
主要结局
OX-LDL
时间窗: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
次要结局
- Blood Pressure(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
- LDL/HDL(8 weeks- {45 days wash out, crossed }- 8 weeks after crossed)
- LDL(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
- Triglyceride(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
- HDL(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
- Body Mass Index(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
- Total Cholesterol(8 weeks -{45 days wash out, crossed }- 8 weeks after crossed)
