Clinical trial NCT00713167: The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Official title: Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Keywords: Grape Seed Extract
Hyperlipidemia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tabriz University
First posted: 2008-07-11
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: OX-LDL
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Secondary outcomes:
measure: LDL
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: HDL
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: Blood Pressure
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: Triglyceride
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: Total Cholesterol
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: Body Mass Index
timeFrame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
measure: LDL/HDL
timeFrame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Ghorbanihaghjo
state: East Azarbayejan
city: Tehran
country: Iran, Islamic Republic of
facility: Maryam
Study officials:
affiliation: Shahid Beheshti University (MC)
name: Maryam Keshtkar-Jahromi, MD,
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University (MC)
name: Hassan Argani, MD
role: STUDY_CHAIR
affiliation: Tabriz University
name: Abbas Delazar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University (MC)
name: Ali Eskandari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University (MC)
name: Sharareh Gholamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University (MC)
name: Seyed Mostafa Razavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s0027-5107(02)00324-x.
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. doi: 10.1093/ajcn/75.5.894.
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. doi: 10.2174/1389201013378725.
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. doi: 10.1016/s0306-3623(97)00332-7.
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. doi: 10.1016/s0021-9150(98)00230-5.
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. doi: 10.1097/01.fjc.0000242058.72471.0c.
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. doi: 10.1016/s0026-0495(03)00192-6.