Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

University of Mississippi

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperlipidemia; Oxidative Stress; Blood Pressure

Treatments: Drug: Pterostilbene 125 mg twice daily; Drug: Grape Extract; Drug: Placebo; Drug: Pterostilbene 50 mg twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT01267227

2010-0225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

High Dose

Active Comparator group

Description:

Pterostilbene 125 mg twice daily

Treatment:

Drug: Pterostilbene 125 mg twice daily

Low Dose

Active Comparator group

Description:

Pterostilbene 50 mg twice daily

Treatment:

Drug: Pterostilbene 50 mg twice daily

Low Dose Combination

Active Comparator group

Description:

Pterostilbene 50 mg/Grape Extract 100 mg twice daily

Treatment:

Drug: Pterostilbene 50 mg twice daily

Drug: Grape Extract

Placebo

Placebo Comparator group

Description:

Matching placebo twice daily

Treatment:

Drug: Placebo