Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Daniel Riche, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE December 17, 2010
First Posted Date  ICMJE December 28, 2010
Results First Submitted Date  ICMJE March 19, 2013
Results First Posted Date  ICMJE May 3, 2013
Last Update Posted Date January 10, 2018
Study Start Date  ICMJE December 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
LDL [ Time Frame: Baseline and 6-8 weeks ]
Increase in low density lipoprotein (LDL)
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
Lipid Laboratory Markers [ Time Frame: 6-8 weeks ]
Change in baseline TC, LDL-C, triglycerides (TG), high-density lipoprotein-C (HDL-C), or non-HDL-C
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • Blood Pressure [ Time Frame: 6-8 weeks ]
    Reduction in systolic blood pressure versus placebo
  • Subjective Adverse Effects [ Time Frame: Baseline and 6-8 weeks ]
    Number of participants with adverse effects as a measure of safety
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
  • Blood Pressure [ Time Frame: 6-8 weeks ]
    Change in baseline systolic blood pressure and/or diastolic blood pressure
  • Oxidative Stress Markers [ Time Frame: 6-8 weeks ]
    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 ]
    Subjective adverse effects, as well as changes in electrolytes, kidney function, or liver function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Official Title  ICMJE Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperlipidemia
  • Blood Pressure
  • Oxidative Stress
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01267227
Other Study ID Numbers  ICMJE 2010-0225
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Riche, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel M Riche, Pharm.D. University of Mississsippi
PRS Account University of Mississippi Medical Center
Verification Date December 2017

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