NCT01267227

Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.

Detailed description

Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.

Conditions

• Hyperlipidemia
• Blood Pressure
• Oxidative Stress

Interventions

Type	Name	Description
DRUG	Pterostilbene 50 mg twice daily	Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
DRUG	Placebo	Matching placebo by mouth twice daily for 6 to 8 weeks
DRUG	Grape Extract	Grape extract 100 mg twice daily for 6-8 weeks
DRUG	Pterostilbene 125 mg twice daily	Pterostilbene 125 mg twice daily for 6-8 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-12-28
• Last updated: 2018-01-10
• Results posted: 2013-05-03

Locations

1 site across 1 country: United States