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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperlipidemia Blood Pressure Oxidative Stress | Drug: Pterostilbene 50 mg twice daily Drug: Placebo Drug: Grape Extract Drug: Pterostilbene 125 mg twice daily | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: High Dose
Pterostilbene 125 mg twice daily
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Drug: Pterostilbene 125 mg twice daily
Pterostilbene 125 mg twice daily for 6-8 weeks
Other Name: pTeropure |
Active Comparator: Low Dose
Pterostilbene 50 mg twice daily
|
Drug: Pterostilbene 50 mg twice daily
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
Other Name: pTeroPure |
Active Comparator: Low Dose Combination
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
|
Drug: Pterostilbene 50 mg twice daily
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
Other Name: pTeroPure Drug: Grape Extract Grape extract 100 mg twice daily for 6-8 weeks
Other Name: ShanStar Concord Grape |
Placebo Comparator: Placebo
Matching placebo twice daily
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Drug: Placebo
Matching placebo by mouth twice daily for 6 to 8 weeks |
- LDL [ Time Frame: Baseline and 6-8 weeks ]Increase in low density lipoprotein (LDL)
- Blood Pressure [ Time Frame: 6-8 weeks ]Reduction in systolic blood pressure versus placebo
- Subjective Adverse Effects [ Time Frame: Baseline and 6-8 weeks ]Number of participants with adverse effects as a measure of safety

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Ages Eligible for Study: | 18 Years to 88 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
- Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory
Exclusion Criteria:
- Patients with significant hepatic, renal or gastrointestinal tract disease
- Receiving thiazolidinediones or fibric acid derivatives
- Current overt cardiovascular disease
- Women of reproductive potential not receiving birth control
- Pregnant/nursing women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267227
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 |
Principal Investigator: | Daniel M Riche, Pharm.D. | University of Mississsippi |
Other Publications:
Responsible Party: | Daniel Riche, Assistant Professor of Pharmacy Practice and Medicine, University of Mississippi Medical Center |
ClinicalTrials.gov Identifier: | NCT01267227 |
Other Study ID Numbers: |
2010-0225 |
First Posted: | December 28, 2010 Key Record Dates |
Results First Posted: | May 3, 2013 |
Last Update Posted: | January 10, 2018 |
Last Verified: | December 2017 |
Hyperlipidemia Cholesterol Blood Pressure Oxidative Stress |
Pterostilbene Blueberry Grape Extract |
Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |