Expired Study
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Jackson, Mississippi 39216


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy - Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory Exclusion Criteria: - Patients with significant hepatic, renal or gastrointestinal tract disease - Receiving thiazolidinediones or fibric acid derivatives - Current overt cardiovascular disease - Women of reproductive potential not receiving birth control - Pregnant/nursing women


NCT ID:

NCT01267227


Primary Contact:

Principal Investigator
Daniel M Riche, Pharm.D.
University of Mississsippi


Backup Contact:

N/A


Location Contact:

Jackson, Mississippi 39216
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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