Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01267227
First received: December 17, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Blood Pressure
Oxidative Stress
Drug: Pterostilbene 50 mg twice daily
Drug: Placebo
Drug: Grape Extract
Drug: Pterostilbene 125 mg twice daily
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Triglycerides [ Time Frame: Baseline and 6-8 weeks ] [ Designated as safety issue: No ]
    Change in baseline triglycerides (TG)


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    Change in baseline systolic blood pressure and/or diastolic blood pressure

  • Subjective Adverse Effects [ Time Frame: Baseline and 6-8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse effects as a measure of safety


Enrollment: 80
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: pTeroPure
Drug: Grape Extract
Grape extract 100 mg twice daily for 6-8 weeks
Other Name: ShanStar Concord Grape
Placebo Comparator: Placebo
Matching placebo twice daily
Drug: Placebo
Matching placebo by mouth twice daily for 6 to 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267227

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississsippi
  More Information

Additional Information:
Publications:
Responsible Party: Daniel Riche, Assistant Professor of Pharmacy Practice and Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01267227     History of Changes
Other Study ID Numbers: 2010-0225
Study First Received: December 17, 2010
Results First Received: March 19, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Hyperlipidemia
Cholesterol
Blood Pressure
Oxidative Stress
Pterostilbene
Blueberry
Grape Extract

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 23, 2014