CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Grape Seed Extract (Vitagrape) +1 moredrug
Likely dose
Placebo of Grape Seed Extract 17mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00713167
NCT00713167Phase 3Completed

Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia

Shahid Beheshti University of Medical Sciences·interventional·Posted Jul 11, 2008·Updated May 21, 2009

In Brief

A Phase 3 clinical trial evaluating Grape Seed Extract (Vitagrape) and Placebo of Grape Seed Extract for Hyperlipidemia. Completed, enrolled 55 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesIran
CollaboratorsTabriz University

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago

Interventions

Grape Seed Extract (Vitagrape)drug

Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months

Placebo of Grape Seed Extractdrug

Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months