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Sponsors and Collaborators: |
Shaheed Beheshti Medical University Tabriz University |
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Information provided by: | Shaheed Beheshti Medical University |
ClinicalTrials.gov Identifier: | NCT00713167 |
Grape seed extract reduces the lipid profile and OX - LDL in mild hyper lipidemic subjects.
Condition | Intervention | Phase |
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Hyperlipidemia |
Drug: Grape Seed Extract Drug: Placebo of Grape Seed Extract |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia |
Estimated Enrollment: | 55 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Grape Seed Extract: Experimental
Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
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Drug: Grape Seed Extract
Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months |
Placebo: Placebo Comparator
Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
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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 |
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.(1) Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans.(2) It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia.(3) 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.(6) 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.(8) Based on these observations, we decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Maryam | |
Tehran, Iran, Islamic Republic of, 19814 | |
Iran, Islamic Republic of, East Azarbayejan | |
Ghorbanihaghjo | |
Tabriz, East Azarbayejan, Iran, Islamic Republic of, ------ |
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) |
Responsible Party: | Shahid Beheshti University (MC) ( Maryam Keshtkar Jahromi ) |
Study ID Numbers: | SBMU 87-01-106-5694 |
Study First Received: | July 8, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00713167 |
Health Authority: | Iran: Ministry of Health |
Grape Seed Extract Hyperlipidemia |
Metabolic Diseases Hyperlipidemias Metabolic disorder Dyslipidemias Lipid Metabolism Disorders |