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Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

This study has been completed.
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center Identifier:
First received: December 17, 2010
Last updated: May 2, 2013
Last verified: May 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
   High Dose   Low Dose   Low Dose Combination   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   20   80 
[Units: Participants]
<=18 years   0   0   0   0   0 
Between 18 and 65 years   16   19   17   17   69 
>=65 years   4   1   3   3   11 
[Units: Years]
Mean (Standard Deviation)
 53.6  (11.2)   53.6  (7.9)   53.0  (13.7)   54.4  (11.9)   53.6  (11.2) 
[Units: Participants]
Female   14   15   15   13   57 
Male   6   5   5   7   23 
Region of Enrollment 
[Units: Participants]
United States   20   20   20   20   80 

  Outcome Measures
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1.  Primary:   Triglycerides   [ Time Frame: Baseline and 6-8 weeks ]

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

3.  Secondary:   Blood Pressure   [ Time Frame: 6-8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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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