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临床试验/NCT00713167
NCT00713167已完成2 期

Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules

干预措施: Grape Seed Extract (Vitagrape) (Drug)

Placebo

Placebo Comparator

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)

研究者

研究点 (2)

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