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

NCT00713167 | Completed Phase 2 DMC

• 1 other identifier: SBMU 87-01-106-5694
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperlipidemia

Keywords

Grape Seed Extract; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• OX-LDL

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Secondary Outcomes (7)

• LDL

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

• HDL

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

• Blood Pressure

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

• Triglyceride

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

• Total Cholesterol

  8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Study Arms (2)

Grape Seed Extract

EXPERIMENTAL

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

Drug: Grape Seed Extract (Vitagrape)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo of Grape Seed Extract

Interventions

Grape Seed Extract (Vitagrape) DRUG

Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months

Also known as: Vitagrape, Iran Ministry of Health Registration Number: 5/92/43198

Grape Seed Extract

Placebo of Grape Seed Extract DRUG

Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months

Placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Triglyceride \> 150 mg/dl
• Total Cholesterol \> 200 mg/dl

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead
• Tabriz University: collaborator

Study Sites (2)

Ghorbanihaghjo

Tabriz, East Azarbayejan, Iran

Location

Maryam

Tehran, Tehran Province, 19814, Iran

Location

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

  PMID: 10962138 BACKGROUND

• 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.

  PMID: 12628506 BACKGROUND

• 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.

  PMID: 11976164 BACKGROUND

• 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.

  PMID: 11480422 BACKGROUND

• 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.

  PMID: 9559333 BACKGROUND

• 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.

  PMID: 9920515 BACKGROUND

• 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.

  PMID: 16954821 BACKGROUND

• 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.

  PMID: 14564675 BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Maryam Keshtkar-Jahromi, MD,

  Shahid Beheshti University (MC)

  STUDY DIRECTOR

• Hassan Argani, MD

  Shahid Beheshti University (MC)

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

IR (2)