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Trial record 1 of 1 for:    01267227
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Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

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ClinicalTrials.gov Identifier: NCT01267227
Recruitment Status : Completed
First Posted : December 28, 2010
Results First Posted : May 3, 2013
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Study Start Date : December 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. LDL [ Time Frame: Baseline and 6-8 weeks ]
    Increase in low density lipoprotein (LDL)


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 6-8 weeks ]
    Reduction in systolic blood pressure versus placebo

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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Satheesh AM, Pari L. Effect of pterostilbene on lipids and lipid profiles in streptozotocin-nicotinamide induced type 2 diabetes mellitus. Journal of Applied Biomedine 6(1):31-37, 2008.

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
First Posted: December 28, 2010    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: January 10, 2018
Last Verified: December 2017

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

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