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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
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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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
No text entered.

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

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
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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
  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 ]

Measure Type Primary
Measure Title Triglycerides
Measure Description Change in baseline triglycerides (TG)
Time Frame Baseline and 6-8 weeks  
Safety Issue No  

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
  Description
High Dose Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
Low Dose Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
Low Dose Combination Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
Placebo Matching placebo twice daily. Unadjusted change from baseline.

Measured Values
    High Dose     Low Dose     Low Dose Combination     Placebo  
Number of Participants Analyzed  
[units: participants]
  20     20     20     20  
Triglycerides  
[units: mg/dL]
Mean ( Full Range )
  14.6  
  ( -42.4 to 285.1 )  
  22.9  
  ( -48.6 to 157 )  
  14.4  
  ( -34 to 282.8 )  
  9.2  
  ( -59.4 to 67.7 )  

No statistical analysis provided for Triglycerides



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

Measure Type Secondary
Measure Title Subjective Adverse Effects
Measure Description Number of participants with adverse effects as a measure of safety
Time Frame Baseline and 6-8 weeks  
Safety Issue Yes  

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
  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

Measured Values
    High Dose     Low Dose     Low Dose Combination     Placebo  
Number of Participants Analyzed  
[units: participants]
  20     20     20     20  
Subjective Adverse Effects  
[units: participants]
  5     3     2     2  

No statistical analysis provided for Subjective Adverse Effects



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


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Daniel Riche
Organization: University of Mississippi
phone: 601-984-2640
e-mail: driche@umc.edu


Publications of Results:

Responsible Party: Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01267227     History of Changes
Other Study ID Numbers: 2010-0225
Study First Received: December 17, 2010
Results First Received: March 19, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board