Trial record 1 of 1 for:    01267227
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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

December 17, 2010
May 2, 2013
December 2010
February 2012   (final data collection date for primary outcome measure)
Triglycerides [ Time Frame: Baseline and 6-8 weeks ] [ Designated as safety issue: No ]
Change in baseline triglycerides (TG)
Lipid laboratory markers [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
Change in baseline TC, LDL-C, triglycerides (TG), high-density lipoprotein-C (HDL-C), or non-HDL-C
Complete list of historical versions of study NCT01267227 on ClinicalTrials.gov Archive Site
  • 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
  • Blood Pressure [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    Change in baseline systolic blood pressure and/or diastolic blood pressure
  • Oxidative Stress Markers [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    Change in baseline urine markers of stress (iPF2-Alpha-III/creat; iPF2-Alpha-VI/creat; 2,3 Dinor iPF2 Alpha III/creat)
  • Number of Participants With Adverse Effects as a Measure of Safety and Tolerability. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]
    Subjective adverse effects, as well as changes in electrolytes, kidney function, or liver function
Not Provided
Not Provided
 
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Blood Pressure
  • Oxidative Stress
  • Drug: Pterostilbene 50 mg twice daily
    Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
    Other Name: pTeroPure
  • Drug: Placebo
    Matching placebo by mouth twice daily for 6 to 8 weeks
  • Drug: Grape Extract
    Grape extract 100 mg twice daily for 6-8 weeks
    Other Name: ShanStar Concord Grape
  • Drug: Pterostilbene 125 mg twice daily
    Pterostilbene 125 mg twice daily for 6-8 weeks
    Other Name: pTeropure
  • Active Comparator: High Dose
    Pterostilbene 125 mg twice daily
    Intervention: Drug: Pterostilbene 125 mg twice daily
  • Active Comparator: Low Dose
    Pterostilbene 50 mg twice daily
    Intervention: Drug: Pterostilbene 50 mg twice daily
  • Active Comparator: Low Dose Combination
    Pterostilbene 50 mg/Grape Extract 100 mg twice daily
    Interventions:
    • Drug: Pterostilbene 50 mg twice daily
    • Drug: Grape Extract
  • Placebo Comparator: Placebo
    Matching placebo twice daily
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01267227
2010-0225
No
Daniel Riche, University of Mississippi Medical Center
University of Mississippi Medical Center
Not Provided
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississsippi
University of Mississippi Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP