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Completed

NCT Number: NCT00713167

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

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.

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ghorbanihaghjo, Tabriz, East Azarbayejan, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Triglyceride > 150 mg/dl
  • Total Cholesterol > 200 mg/dl

Exclusion criteria

  • Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl)
  • Usage of antilipid drugs
  • Herbivore Diet
  • Alcoholism
  • Heart failure
  • Known cases of any malignancy
  • BMI > 30 kg/M2
  • Chronic Hepatic Diseases
  • Smoking
  • Chronic Renal Failure

Treatment and study plan

Grape Seed Extract (Vitagrape)

Drug

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 of Grape Seed Extract

Drug

Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}

1 capsule twice daily for 2 months

Primary outcomes

  1. OX-LDL

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Secondary outcomes

  1. LDL

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  2. HDL

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  3. Blood Pressure

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  4. Triglyceride

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  5. Total Cholesterol

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  6. Body Mass Index

    Time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  7. LDL/HDL

    Time frame: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Collaborators

  • Tabriz University

Registry information

Official study title

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

Acronym: GSE

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jul 11, 2008
Registry last updated
May 21, 2009

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.

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