Grape Seed Extract (Vitagrape)
DrugDrug {Each Containing: Grape Seed Extract100 mg +...}
1 capsule twice daily for 2 months
Other names: Vitagrape, Iran Ministry of Health Registration Number: 5/92/43198
NCT Number: NCT00713167
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.
Looking for future studies?
Notify Me21 year–64 year
All sexes
Interventional
Phase 2 / Phase 3
Ghorbanihaghjo, Tabriz, East Azarbayejan, Iran
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug {Each Containing: Grape Seed Extract100 mg +...}
1 capsule twice daily for 2 months
Other names: Vitagrape, Iran Ministry of Health Registration Number: 5/92/43198
Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}
1 capsule twice daily for 2 months
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Time frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed
Shahid Beheshti University of Medical Sciences
Other
Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia
Acronym: GSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07710898
Diabete Mellitus, Diabetes Mellitus
Lahore, Pakistan
View Trial DetailsNCT07696559
Dyslipidemias, Hyperlipidemia
Lahore, Pakistan
View Trial DetailsNCT00001154
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dyslipidemia
Bethesda, Maryland, United States
View Trial DetailsNCT01212159
Dyslipidemias, Hyperlipidemia
Philadelphia, Pennsylvania, United States
View Trial Details