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Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.
Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Active Comparator | Pterostilbene 125 mg twice daily |
|
| Low Dose | Active Comparator | Pterostilbene 50 mg twice daily |
|
| Low Dose Combination | Active Comparator | Pterostilbene 50 mg/Grape Extract 100 mg twice daily |
|
| Placebo | Placebo Comparator | Matching placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pterostilbene 50 mg twice daily | Drug | Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL | Increase in low density lipoprotein (LDL) | Baseline and 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Reduction in systolic blood pressure versus placebo | 6-8 weeks |
| Subjective Adverse Effects | Number of participants with adverse effects as a measure of safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Riche, Pharm.D. | University of Mississsippi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19549798 | Background | Paul S, Rimando AM, Lee HJ, Ji Y, Reddy BS, Suh N. Anti-inflammatory action of pterostilbene is mediated through the p38 mitogen-activated protein kinase pathway in colon cancer cells. Cancer Prev Res (Phila). 2009 Jul;2(7):650-7. doi: 10.1158/1940-6207.CAPR-08-0224. Epub 2009 Jun 23. | |
| 15264904 | Background |
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Medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | Pterostilbene 125 mg twice daily |
| FG001 | Low Dose | Pterostilbene 50 mg twice daily |
| FG002 | Low Dose Combination | Pterostilbene 50 mg/Grape Extract 100 mg twice daily |
| FG003 | Placebo | Matching placebo twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | Pterostilbene 125 mg twice daily |
| BG001 | Low Dose | Pterostilbene 50 mg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL | Increase in low density lipoprotein (LDL) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 6-8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | Pterostilbene 125 mg twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Riche | University of Mississippi | 601-984-2640 | driche@umc.edu |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000721168 | Pterocarpus marsupium |
| C000722782 | whole grape extract |
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| Placebo | Drug | Matching placebo by mouth twice daily for 6 to 8 weeks |
|
| Grape Extract | Drug | Grape extract 100 mg twice daily for 6-8 weeks |
|
|
| Pterostilbene 125 mg twice daily | Drug | Pterostilbene 125 mg twice daily for 6-8 weeks |
|
|
| Baseline and 6-8 weeks |
| Rimando AM, Kalt W, Magee JB, Dewey J, Ballington JR. Resveratrol, pterostilbene, and piceatannol in vaccinium berries. J Agric Food Chem. 2004 Jul 28;52(15):4713-9. doi: 10.1021/jf040095e. |
| 15853379 | Background | Rimando AM, Nagmani R, Feller DR, Yokoyama W. Pterostilbene, a new agonist for the peroxisome proliferator-activated receptor alpha-isoform, lowers plasma lipoproteins and cholesterol in hypercholesterolemic hamsters. J Agric Food Chem. 2005 May 4;53(9):3403-7. doi: 10.1021/jf0580364. |
| 17132211 | Background | Amarnath Satheesh M, Pari L. The antioxidant role of pterostilbene in streptozotocin-nicotinamide-induced type 2 diabetes mellitus in Wistar rats. J Pharm Pharmacol. 2006 Nov;58(11):1483-90. doi: 10.1211/jpp.58.11.0009. |
| Background | Satheesh AM, Pari L. Effect of pterostilbene on lipids and lipid profiles in streptozotocin-nicotinamide induced type 2 diabetes mellitus. Journal of Applied Biomedine 6(1):31-37, 2008. |
| 25057276 | Result | Riche DM, Riche KD, Blackshear CT, McEwen CL, Sherman JJ, Wofford MR, Griswold ME. Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial. Evid Based Complement Alternat Med. 2014;2014:459165. doi: 10.1155/2014/459165. Epub 2014 Jun 25. |
| 23431291 | Result | Riche DM, McEwen CL, Riche KD, Sherman JJ, Wofford MR, Deschamp D, Griswold M. Analysis of safety from a human clinical trial with pterostilbene. J Toxicol. 2013;2013:463595. doi: 10.1155/2013/463595. Epub 2013 Feb 4. |
| BG002 |
| Low Dose Combination |
Pterostilbene 50 mg/Grape Extract 100 mg twice daily |
| BG003 | Placebo | Matching placebo twice daily |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo | Matching placebo twice daily. Unadjusted change from baseline. |
|
|
| Secondary | Blood Pressure | Reduction in systolic blood pressure versus placebo | Posted | Mean | 95% Confidence Interval | mmHg | 6-8 weeks |
|
|
|
| Secondary | Subjective Adverse Effects | Number of participants with adverse effects as a measure of safety | Posted | Number | participants | Baseline and 6-8 weeks |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Low Dose | Pterostilbene 50 mg twice daily | 0 | 20 | 3 | 20 |
| EG002 | Low Dose Combination | Pterostilbene 50 mg/Grape Extract 100 mg twice daily | 0 | 20 | 2 | 20 |
| EG003 | Placebo | Matching placebo twice daily | 0 | 20 | 2 | 20 |
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Itching | General disorders | Non-systematic Assessment |
|
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