The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL) (GSE)
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Grape Seed Extract (Vitagrape)
Placebo of Grape Seed Extract
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Grape Seed Extract, Hyperlipidemia
Eligibility 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
Sites / Locations
- Ghorbanihaghjo
- Maryam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Grape Seed Extract
Placebo
Arm Description
Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
Outcomes
Primary Outcome Measures
OX-LDL
Secondary Outcome Measures
LDL
HDL
Blood Pressure
Triglyceride
Total Cholesterol
Body Mass Index
LDL/HDL
Full Information
NCT ID
NCT00713167
First Posted
July 8, 2008
Last Updated
May 20, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Tabriz University
1. Study Identification
Unique Protocol Identification Number
NCT00713167
Brief Title
The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Acronym
GSE
Official Title
Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
Collaborators
Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Grape Seed Extract, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grape Seed Extract
Arm Type
Experimental
Arm Description
Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
Intervention Type
Drug
Intervention Name(s)
Grape Seed Extract (Vitagrape)
Other Intervention Name(s)
Vitagrape, Iran Ministry of Health Registration Number: 5/92/43198
Intervention Description
Drug {Each Containing: Grape Seed Extract100 mg +...}
1 capsule twice daily for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo of Grape Seed Extract
Intervention Description
Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}
1 capsule twice daily for 2 months
Primary Outcome Measure Information:
Title
OX-LDL
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Secondary Outcome Measure Information:
Title
LDL
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
HDL
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
Blood Pressure
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
Triglyceride
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
Total Cholesterol
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
Body Mass Index
Time Frame
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Title
LDL/HDL
Time Frame
8 weeks- {45 days wash out, crossed }- 8 weeks after crossed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Keshtkar-Jahromi, MD,
Organizational Affiliation
Shahid Beheshti University (MC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hassan Argani, MD
Organizational Affiliation
Shahid Beheshti University (MC)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abbas Delazar, PhD
Organizational Affiliation
Tabriz University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Eskandari, MD
Organizational Affiliation
Shahid Beheshti University (MC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharareh Gholamin, MD
Organizational Affiliation
Shahid Beheshti University (MC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seyed Mostafa Razavi, MD
Organizational Affiliation
Shahid Beheshti University (MC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghorbanihaghjo
City
Tabriz
State/Province
East Azarbayejan
Country
Iran, Islamic Republic of
Facility Name
Maryam
City
Tehran
ZIP/Postal Code
19814
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
10962138
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.
Results Reference
background
PubMed Identifier
12628506
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.
Results Reference
background
PubMed Identifier
11976164
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.
Results Reference
background
PubMed Identifier
11480422
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.
Results Reference
background
PubMed Identifier
9559333
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.
Results Reference
background
PubMed Identifier
9920515
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.
Results Reference
background
PubMed Identifier
16954821
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.
Results Reference
background
PubMed Identifier
14564675
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.
Results Reference
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The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
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