Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress |
- Triglycerides [ Time Frame: Baseline and 6-8 weeks ] [ Designated as safety issue: No ]Change in baseline triglycerides (TG)
- Blood Pressure [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]Change in baseline systolic blood pressure and/or diastolic blood pressure
- Subjective Adverse Effects [ Time Frame: Baseline and 6-8 weeks ] [ Designated as safety issue: Yes ]Number of participants with adverse effects as a measure of safety
| Enrollment: | 80 |
| Study Start Date: | December 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: High Dose
Pterostilbene 125 mg twice daily
|
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
|
Drug: Placebo
Matching placebo by mouth twice daily for 6 to 8 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| Principal Investigator: | Daniel M Riche, Pharm.D. | University of Mississsippi |
More Information
Additional Information:
Publications:
| Responsible Party: | Daniel Riche, Assistant Professor of Pharmacy Practice and Medicine, 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 |
Keywords provided by University of Mississippi Medical Center:
|
Hyperlipidemia Cholesterol Blood Pressure Oxidative Stress |
Pterostilbene Blueberry Grape Extract |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013