The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Grape Seed Extract (Vitagrape)
* Drug: Placebo of Grape Seed Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Triglyceride > 150 mg/dl Total Cholesterol > 200 mg/dl Exclusion Criteria: Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl) Usage of antilipid drugs Herbivore Diet Alcoholism Heart failure Known cases of any malignancy BMI > 30 kg/M2 Chronic Hepatic Diseases Smoking Chronic Renal Failure

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grape Seed Extract<br>Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules | Drug: Grape Seed Extract (Vitagrape)<br>* Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months<br>* Other names: Iran Ministry of Health Registration Number: 5/92/43198;|
| Placebo Comparator: Placebo<br>Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract | Drug: Placebo of Grape Seed Extract<br>* Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OX-LDL |  | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL |  | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed | 
| HDL |  | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed | 
| Blood Pressure |  | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed | 
| Triglyceride |  | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed | 
| Total Cholesterol |  | 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 | 
| LDL/HDL |  | 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grape Seed Extract, Hyperlipidemia