Hyperlipidemia
Conditions
Keywords
Grape Seed Extract, Hyperlipidemia
Brief 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.
Interventions
DRUGGrape Seed Extract (Vitagrape)
Drug {Each Containing: Grape Seed Extract100 mg +...} 1 capsule twice daily for 2 months
DRUGPlacebo of Grape Seed Extract
Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg} 1 capsule twice daily for 2 months
Sponsors
Tabriz University
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OX-LDL | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
Secondary
| Measure | Time frame |
|---|---|
| HDL | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
| Blood Pressure | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
| Triglyceride | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
| LDL | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
| Body Mass Index | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
| LDL/HDL | 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed |
| Total Cholesterol | 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed |
Countries
Iran
Outcome results
None listed