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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months
Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months
Ghorbanihaghjo
Tabriz, East Azarbayejan, Iran
Maryam
Tehran, Tehran Province, Iran
OX-LDL
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
LDL
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
HDL
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Blood Pressure
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Triglyceride
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Total Cholesterol
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Body Mass Index
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
LDL/HDL
Time frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed
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