Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

December 11, 2017 updated by: Daniel Riche, University of Mississippi Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on Pterostilbene 125 mg twice daily

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe