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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: Grape Seed Extract (Vitagrape); Drug: Placebo of Grape Seed Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT00713167

SBMU 87-01-106-5694

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Grape Seed Extract

Experimental group

Description:

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

Treatment:

Drug: Grape Seed Extract (Vitagrape)

Placebo

Placebo Comparator group

Description:

Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract

Treatment:

Drug: Placebo of Grape Seed Extract