The Efficacy of Red Grape Seed Extract on Lipid Profile and OX-LDL - Full Text View

Sponsors and Collaborators:	Shaheed Beheshti Medical University Tabriz University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00713167

Purpose

Grape seed extract reduces the lipid profile and OX - LDL in mild hyper lipidemic subjects.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Grape Seed Extract Drug: Placebo of Grape Seed Extract	Phase II Phase III

Drug Information available for: Cellulose Cellulose sodium phosphate Phosphocellulose Lipids Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

OX-LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
HDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
Blood Pressure [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
Triglyceride [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
Total Cholesterol [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
Body Mass Index [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
LDL/HDL [ Time Frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Grape Seed Extract: Experimental Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules	Drug: Grape Seed Extract Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months
Placebo: Placebo Comparator Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract	Drug: 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

Detailed Description:

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.(1) Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans.(2) It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia.(3) 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.(6) 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.(8) Based on these observations, we decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.

Eligibility

Ages Eligible for Study:	21 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713167

Locations

Iran, Islamic Republic of
Maryam
Tehran, Iran, Islamic Republic of, 19814
Iran, Islamic Republic of, East Azarbayejan
Ghorbanihaghjo
Tabriz, East Azarbayejan, Iran, Islamic Republic of, ------

Sponsors and Collaborators

Shaheed Beheshti Medical University

Tabriz University

Investigators

Study Director:	Maryam Keshtkar-Jahromi, MD,	Shahid Beheshti University (MC)
Study Chair:	Hassan Argani, MD	Shahid Beheshti University (MC)
Principal Investigator:	Abbas Delazar, PhD	Tabriz University
Principal Investigator:	Ali Eskandari, MD	Shahid Beheshti University (MC)
Principal Investigator:	Sharareh Gholamin, MD	Shahid Beheshti University (MC)
Principal Investigator:	Seyed Mostafa Razavi, MD	Shahid Beheshti University (MC)

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Shahid Beheshti University (MC) ( Maryam Keshtkar Jahromi )
Study ID Numbers:	SBMU 87-01-106-5694
Study First Received:	July 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00713167
Health Authority:	Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:

Grape Seed Extract
Hyperlipidemia

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009