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Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

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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

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


  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 		 20   20   20   20   80 
Age 
[Units: Participants]
Count of Participants 		         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16  80.0%      19  95.0%      17  85.0%      17  85.0%      69  86.3% 
>=65 years      4  20.0%      1   5.0%      3  15.0%      3  15.0%      11  13.8% 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		         
Female      14  70.0%      15  75.0%      15  75.0%      13  65.0%      57  71.3% 
Male      6  30.0%      5  25.0%      5  25.0%      7  35.0%      23  28.7% 
Region of Enrollment 
[Units: Participants]
 		         
United States   20   20   20   20   80 


  Outcome Measures

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

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

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


  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