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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
Enrollment 80
Recruitment Details Medical clinic
Pre-assignment Details  
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo
Hide Arm/Group Description Pterostilbene 125 mg twice daily Pterostilbene 50 mg twice daily Pterostilbene 50 mg/Grape Extract 100 mg twice daily Matching placebo twice daily
Period Title: Overall Study
Started 20 20 20 20
Completed 19 19 18 17
Not Completed 1 1 2 3
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo Total
Hide Arm/Group Description Pterostilbene 125 mg twice daily Pterostilbene 50 mg twice daily Pterostilbene 50 mg/Grape Extract 100 mg twice daily Matching placebo twice daily Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
53.6  (11.2) 53.6  (7.9) 53.0  (13.7) 54.4  (11.9) 53.6  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
20 20 20 20 80
1.Primary Outcome
Title LDL
Hide Description Increase in low density lipoprotein (LDL)
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo
Hide Arm/Group Description:
Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
Matching placebo twice daily. Unadjusted change from baseline.
Overall Number of Participants Analyzed 20 20 20 20
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
19.67
(5.28 to 34.05)
20.04
(5.68 to 34.40)
5.33
(-9.16 to 19.82)
0
(0 to 0)
2.Secondary Outcome
Title Blood Pressure
Hide Description Reduction in systolic blood pressure versus placebo
Time Frame 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo
Hide Arm/Group Description:
Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
Matching placebo twice daily. Unadjusted change from baseline.
Overall Number of Participants Analyzed 20 20 20 20
Mean (95% Confidence Interval)
Unit of Measure: mmHg
7.77
(2.38 to 13.17)
3.67
(-1.74 to 9.09)
6.72
(1.25 to 12.18)
0
(0 to 0)
3.Secondary Outcome
Title Subjective Adverse Effects
Hide Description Number of participants with adverse effects as a measure of safety
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo
Hide Arm/Group Description:
Pterostilbene 125 mg twice daily
Pterostilbene 50 mg twice daily
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Matching placebo twice daily
Overall Number of Participants Analyzed 20 20 20 20
Measure Type: Number
Unit of Measure: participants
5 3 2 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Low Dose Low Dose Combination Placebo
Hide Arm/Group Description Pterostilbene 125 mg twice daily Pterostilbene 50 mg twice daily Pterostilbene 50 mg/Grape Extract 100 mg twice daily Matching placebo twice daily
All-Cause Mortality
High Dose Low Dose Low Dose Combination Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
High Dose Low Dose Low Dose Combination Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Low Dose Low Dose Combination Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      3/20 (15.00%)      2/20 (10.00%)      2/20 (10.00%)    
Gastrointestinal disorders         
GI   4/20 (20.00%)  4 1/20 (5.00%)  1 1/20 (5.00%)  1 1/20 (5.00%)  1
General disorders         
Itching *  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders         
Muscle Pain   0/20 (0.00%)  0 2/20 (10.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
Disclosure of the submitted materials approved per contractual agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Riche
Organization: University of Mississippi
Phone: 601-984-2640
EMail: driche@umc.edu
Layout table for additonal information
Responsible Party: Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01267227    
Other Study ID Numbers: 2010-0225
First Submitted: December 17, 2010
First Posted: December 28, 2010
Results First Submitted: March 19, 2013
Results First Posted: May 3, 2013
Last Update Posted: January 10, 2018