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

Hyperlipidemia Clinical Trial

— GSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713167
• Other study ID #: SBMU 87-01-106-5694
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 8, 2008
• Last updated: May 20, 2009
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: May 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Grape Seed Extract (Vitagrape)
Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months
• Placebo of Grape Seed Extract
Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ghorbanihaghjo	Tabriz	East Azarbayejan
Iran, Islamic Republic of	Maryam	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences	Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (8)

Bagchi D, Bagchi M, Stohs SJ, Das DK, Ray SD, Kuszynski CA, Joshi SS, Pruess HG. Free radicals and grape seed proanthocyanidin extract: importance in human health and disease prevention. Toxicology. 2000 Aug 7;148(2-3):187-97. — View Citation

Bagchi D, Garg A, Krohn RL, Bagchi M, Bagchi DJ, Balmoori J, Stohs SJ. Protective effects of grape seed proanthocyanidins and selected antioxidants against TPA-induced hepatic and brain lipid peroxidation and DNA fragmentation, and peritoneal macrophage activation in mice. Gen Pharmacol. 1998 May;30(5):771-6. — View Citation

Bagchi D, Sen CK, Ray SD, Das DK, Bagchi M, Preuss HG, Vinson JA. Molecular mechanisms of cardioprotection by a novel grape seed proanthocyanidin extract. Mutat Res. 2003 Feb-Mar;523-524:87-97. Review. — View Citation

Joshi SS, Kuszynski CA, Bagchi D. The cellular and molecular basis of health benefits of grape seed proanthocyanidin extract. Curr Pharm Biotechnol. 2001 Jun;2(2):187-200. — View Citation

Pataki T, Bak I, Kovacs P, Bagchi D, Das DK, Tosaki A. Grape seed proanthocyanidins improved cardiac recovery during reperfusion after ischemia in isolated rat hearts. Am J Clin Nutr. 2002 May;75(5):894-9. — View Citation

Vigna GB, Costantini F, Aldini G, Carini M, Catapano A, Schena F, Tangerini A, Zanca R, Bombardelli E, Morazzoni P, Mezzetti A, Fellin R, Maffei Facino R. Effect of a standardized grape seed extract on low-density lipoprotein susceptibility to oxidation in heavy smokers. Metabolism. 2003 Oct;52(10):1250-7. — View Citation

Yamakoshi J, Kataoka S, Koga T, Ariga T. Proanthocyanidin-rich extract from grape seeds attenuates the development of aortic atherosclerosis in cholesterol-fed rabbits. Atherosclerosis. 1999 Jan;142(1):139-49. — View Citation

Zhang FL, Gao HQ, Wu JM, Ma YB, You BA, Li BY, Xuan JH. Selective inhibition by grape seed proanthocyanidin extracts of cell adhesion molecule expression induced by advanced glycation end products in endothelial cells. J Cardiovasc Pharmacol. 2006 Aug;48(2):47-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OX-LDL		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	LDL		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	HDL		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	Blood Pressure		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	Triglyceride		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	Total Cholesterol		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	Body Mass Index		8 weeks -{45 days wash out, crossed }- 8 weeks after crossed	No
Secondary	LDL/HDL		8 weeks- {45 days wash out, crossed }- 8 weeks after crossed	No