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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
Matching placebo by mouth twice daily for 6 to 8 weeks
Grape extract 100 mg twice daily for 6-8 weeks
Pterostilbene 125 mg twice daily for 6-8 weeks
University of Mississippi Medical Center
Jackson, Mississippi, United States
LDL
Increase in low density lipoprotein (LDL)
Time frame: Baseline and 6-8 weeks
Blood Pressure
Reduction in systolic blood pressure versus placebo
Time frame: 6-8 weeks
Subjective Adverse Effects
Number of participants with adverse effects as a measure of safety
Time frame: Baseline and 6-8 weeks
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