Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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

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Hyperlipidemia Blood Pressure Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High Dose

Pterostilbene 125 mg twice daily

Group Type ACTIVE_COMPARATOR

Pterostilbene 125 mg twice daily

Intervention Type DRUG

Pterostilbene 125 mg twice daily for 6-8 weeks

Low Dose

Pterostilbene 50 mg twice daily

Group Type ACTIVE_COMPARATOR

Pterostilbene 50 mg twice daily

Intervention Type DRUG

Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks

Low Dose Combination

Pterostilbene 50 mg/Grape Extract 100 mg twice daily

Group Type ACTIVE_COMPARATOR

Pterostilbene 50 mg twice daily

Intervention Type DRUG

Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks

Grape Extract

Intervention Type DRUG

Grape extract 100 mg twice daily for 6-8 weeks

Placebo

Matching placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo by mouth twice daily for 6 to 8 weeks

Interventions

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Pterostilbene 50 mg twice daily

Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks

Intervention Type DRUG

Placebo

Matching placebo by mouth twice daily for 6 to 8 weeks

Intervention Type DRUG

Grape Extract

Grape extract 100 mg twice daily for 6-8 weeks

Intervention Type DRUG

Pterostilbene 125 mg twice daily

Pterostilbene 125 mg twice daily for 6-8 weeks

Intervention Type DRUG

Other Intervention Names

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pTeroPure ShanStar Concord Grape pTeropure

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No