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

This study has been completed.
Sponsor:
Collaborator:
Tabriz University
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00713167
First received: July 8, 2008
Last updated: May 20, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: Grape Seed Extract (Vitagrape)
Drug: Placebo of Grape Seed Extract
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • OX-LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • HDL [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • Triglyceride [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • Total Cholesterol [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]
  • LDL/HDL [ Time Frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713167

Locations
Iran, Islamic Republic of
Ghorbanihaghjo
Tabriz, East Azarbayejan, Iran, Islamic Republic of, ------
Maryam
Tehran, Iran, Islamic Republic of, 19814
Sponsors and Collaborators
Shahid Beheshti Medical University
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)
  More Information

Publications:

Responsible Party: Maryam Keshtkar Jahromi, Shahid Beheshti University (MC)
ClinicalTrials.gov Identifier: NCT00713167     History of Changes
Other Study ID Numbers: SBMU 87-01-106-5694
Study First Received: July 8, 2008
Last Updated: May 20, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
Grape Seed Extract
Hyperlipidemia

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Grape Seed Extract
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014