Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Phase 2

Completed

• Conditions: Hyperlipidemia; Blood Pressure; Oxidative Stress
• Interventions: Drug: Pterostilbene 125 mg twice daily; Drug: Pterostilbene 50 mg twice daily; Drug: Placebo; Drug: Grape Extract

• Registration Number: NCT01267227
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-28
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-03-19
• Results First Submitted QC: 2013-03-19
• Results First Posted: 2013-05-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose	Pterostilbene 125 mg twice daily	Pterostilbene 125 mg twice daily
Low Dose Combination	Pterostilbene 50 mg twice daily	Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Low Dose Combination	Grape Extract	Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Placebo	Placebo	Matching placebo twice daily
Low Dose	Pterostilbene 50 mg twice daily	Pterostilbene 50 mg twice daily

Primary Outcome Measures

Name	Time	Method
LDL	Baseline and 6-8 weeks	Increase in low density lipoprotein (LDL)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States