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

• ClinicalTrials.gov Identifier: NCT00713167
• Recruitment Status: Completed
• First Posted: July 11, 2008
• Last Update Posted: May 21, 2009
• Sponsor: Shahid Beheshti University of Medical Sciences
• Collaborator: Tabriz University
• Information provided by: Shahid Beheshti University of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Drug: Grape Seed Extract (Vitagrape); Drug: Placebo of Grape Seed Extract	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
• Study Start Date: July 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Grape Seed Extract; Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules	Drug: Grape Seed Extract (Vitagrape); Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months; Other Names: Vitagrape; Iran Ministry of Health Registration Number: 5/92/43198
Placebo Comparator: Placebo; 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

Outcome Measures

Primary Outcome Measures :

1. OX-LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]

Secondary Outcome Measures :

1. LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
2. HDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
3. Blood Pressure [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
4. Triglyceride [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
5. Total Cholesterol [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
6. Body Mass Index [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ]
7. LDL/HDL [ Time Frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Ghorbanihaghjo

Tabriz, East Azarbayejan, Iran, Islamic Republic of

Maryam

Tehran, Iran, Islamic Republic of, 19814

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

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. doi: 10.1016/s0300-483x(00)00210-9.

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. doi: 10.1016/s0027-5107(02)00324-x.

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. doi: 10.1093/ajcn/75.5.894.

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. doi: 10.2174/1389201013378725.

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. doi: 10.1016/s0306-3623(97)00332-7.

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. doi: 10.1016/s0021-9150(98)00230-5.

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. doi: 10.1097/01.fjc.0000242058.72471.0c.

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. doi: 10.1016/s0026-0495(03)00192-6.

• Responsible Party: Maryam Keshtkar Jahromi, Shahid Beheshti University (MC)
• ClinicalTrials.gov Identifier: NCT00713167
• Other Study ID Numbers: SBMU 87-01-106-5694
• First Posted: July 11, 2008
• Last Update Posted: May 21, 2009
• Last Verified: May 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:

Grape Seed Extract; Hyperlipidemia

Additional relevant MeSH terms:

Grape Seed Extract; Hyperlipidemias; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs