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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
History of Changes
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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  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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
 		  20     20     20     20     80  
Age  
[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  
Age  
[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)  
Gender  
[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 ]
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2.  Secondary:   Subjective Adverse Effects   [ Time Frame: Baseline and 6-8 weeks ]
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3.  Secondary:   Blood Pressure   [ Time Frame: 6-8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  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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  More Information
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