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. Identifier: NCT01267227
Recruitment Status : Completed
First Posted : December 28, 2010
Results First Posted : May 3, 2013
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hyperlipidemia
Blood Pressure
Oxidative Stress
Interventions: Drug: Pterostilbene 50 mg twice daily
Drug: Placebo
Drug: Grape Extract
Drug: Pterostilbene 125 mg twice daily

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
High Dose Pterostilbene 125 mg twice daily
Low Dose Pterostilbene 50 mg twice daily
Low Dose Combination Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Placebo Matching placebo twice daily

Participant Flow:   Overall Study
    High Dose   Low Dose   Low Dose Combination   Placebo
STARTED   20   20   20   20 
COMPLETED   19   19   18   17 
NOT COMPLETED   1   1   2   3 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   LDL   [ Time Frame: Baseline and 6-8 weeks ]

2.  Secondary:   Blood Pressure   [ Time Frame: 6-8 weeks ]

3.  Secondary:   Subjective Adverse Effects   [ Time Frame: Baseline and 6-8 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information