Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT00713167
Status:
COMPLETED
Last Update Posted:
2009-05-21
First Post:
2008-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-20', 'studyFirstSubmitDate': '2008-07-08', 'studyFirstSubmitQcDate': '2008-07-08', 'lastUpdatePostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OX-LDL', 'timeFrame': '8 weeks -{45 days wash out, crossed }- 8 weeks after crossed'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Grape Seed Extract', 'Hyperlipidemia'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '10962138', 'type': 'BACKGROUND', '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.'}, {'pmid': '12628506', 'type': 'BACKGROUND', '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.'}, {'pmid': '11976164', 'type': 'BACKGROUND', '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.'}, {'pmid': '11480422', 'type': 'BACKGROUND', '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.'}, {'pmid': '9559333', 'type': 'BACKGROUND', '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.'}, {'pmid': '9920515', 'type': 'BACKGROUND', '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.'}, {'pmid': '16954821', 'type': 'BACKGROUND', '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.'}, {'pmid': '14564675', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Triglyceride \\> 150 mg/dl\n2. Total Cholesterol \\> 200 mg/dl\n\nExclusion Criteria:\n\n1. Severe hyperlipidemia (Triglyceride \\> 300 mg/dl,Total Cholesterol \\> 250 mg/dl)\n2. Usage of antilipid drugs\n3. Herbivore Diet\n4. Alcoholism\n5. Heart failure\n6. Known cases of any malignancy\n7. BMI \\> 30 kg/M2\n8. Chronic Hepatic Diseases\n9. Smoking\n10. Chronic Renal Failure'}, 'identificationModule': {'nctId': 'NCT00713167', 'acronym': 'GSE', 'briefTitle': 'The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia', 'orgStudyIdInfo': {'id': 'SBMU 87-01-106-5694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grape Seed Extract', 'description': 'Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules', 'interventionNames': ['Drug: Grape Seed Extract (Vitagrape)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract', 'interventionNames': ['Drug: Placebo of Grape Seed Extract']}], 'interventions': [{'name': 'Grape Seed Extract (Vitagrape)', 'type': 'DRUG', 'otherNames': ['Vitagrape', 'Iran Ministry of Health Registration Number: 5/92/43198'], 'description': 'Drug {Each Containing: Grape Seed Extract100 mg +...}\n\n1 capsule twice daily for 2 months', 'armGroupLabels': ['Grape Seed Extract']}, {'name': 'Placebo of Grape Seed Extract', 'type': 'DRUG', 'description': 'Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}\n\n1 capsule twice daily for 2 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tabriz', 'state': 'East Azarbayejan', 'country': 'Iran', 'facility': 'Ghorbanihaghjo', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}, {'zip': '19814', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Maryam', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Maryam Keshtkar-Jahromi, MD,', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shahid Beheshti University (MC)'}, {'name': 'Hassan Argani, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid Beheshti University (MC)'}, {'name': 'Abbas Delazar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabriz University'}, {'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', 'affiliation': 'Shahid Beheshti University (MC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tabriz University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Maryam Keshtkar Jahromi', 'oldOrganization': 'Shahid Beheshti University (MC)'}}}}