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

Phase 2

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Grape Seed Extract (Vitagrape); Drug: Placebo of Grape Seed Extract

• Registration Number: NCT00713167
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-11
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-20
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Triglyceride > 150 mg/dl
2. Total Cholesterol > 200 mg/dl

Exclusion Criteria

1. Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl)
2. Usage of antilipid drugs
3. Herbivore Diet
4. Alcoholism
5. Heart failure
6. Known cases of any malignancy
7. BMI > 30 kg/M2
8. Chronic Hepatic Diseases
9. Smoking
10. Chronic Renal Failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Grape Seed Extract	Grape Seed Extract (Vitagrape)	Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
Placebo	Placebo of Grape Seed Extract	Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract

Primary Outcome Measures

Name	Time	Method
OX-LDL	8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Secondary Outcome Measures

Name	Time	Method
LDL	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
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
Triglyceride	8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
HDL	8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Total Cholesterol	8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Trial Locations

Locations (2)

Maryam; 🇮🇷 Tehran, Iran, Islamic Republic of

Ghorbanihaghjo; 🇮🇷 Tabriz, East Azarbayejan, Iran, Islamic Republic of