Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Study Overview
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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.

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.

Official Title
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Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Conditions
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Hyperlipidemia, Blood Pressure, Oxidative Stress

Intervention / Treatment
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* Drug: Pterostilbene 50 mg twice daily
* Drug: Placebo
* Drug: Grape Extract
* Drug: Pterostilbene 125 mg twice daily


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose<br>Pterostilbene 125 mg twice daily | Drug: Pterostilbene 125 mg twice daily<br>* Pterostilbene 125 mg twice daily for 6-8 weeks<br>* Other names: pTeropure;|
| Active Comparator: Low Dose<br>Pterostilbene 50 mg twice daily | Drug: Pterostilbene 50 mg twice daily<br>* Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks<br>* Other names: pTeroPure;|
| Active Comparator: Low Dose Combination<br>Pterostilbene 50 mg/Grape Extract 100 mg twice daily | Drug: Pterostilbene 50 mg twice daily<br>* Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks<br>* Other names: pTeroPure;Drug: Grape Extract<br>* Grape extract 100 mg twice daily for 6-8 weeks<br>* Other names: ShanStar Concord Grape;|
| Placebo Comparator: Placebo<br>Matching placebo twice daily | Drug: Placebo<br>* Matching placebo by mouth twice daily for 6 to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL | Increase in low density lipoprotein (LDL) | Baseline and 6-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Reduction in systolic blood pressure versus placebo | 6-8 weeks | 
| Subjective Adverse Effects | Number of participants with adverse effects as a measure of safety | Baseline and 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract