The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL) (GSE)

May 20, 2009 updated by: Shahid Beheshti University of Medical Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19814
        • Maryam
    • East Azarbayejan
      • Tabriz, East Azarbayejan, Iran, Islamic Republic of
        • Ghorbanihaghjo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Triglyceride > 150 mg/dl
  2. Total Cholesterol > 200 mg/dl

Exclusion Criteria:

  1. Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl)
  2. Usage of antilipid drugs
  3. Herbivore Diet
  4. Alcoholism
  5. Heart failure
  6. Known cases of any malignancy
  7. BMI > 30 kg/M2
  8. Chronic Hepatic Diseases
  9. Smoking
  10. Chronic Renal Failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grape Seed Extract
Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules
Drug: Grape Seed Extract (Vitagrape)

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 Comparator: Placebo
Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OX-LDL
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
HDL
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Blood Pressure
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Triglyceride
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Total Cholesterol
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
Body Mass Index
Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
8 weeks -{45 days wash out, crossed }- 8 weeks after crossed
LDL/HDL
Time Frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed
8 weeks- {45 days wash out, crossed }- 8 weeks after crossed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Tabriz University

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 20, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU 87-01-106-5694

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperlipidemia

Clinical Trials on Grape Seed Extract (Vitagrape)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe