Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Cholesterol, Other Indications, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 88 |
| Updated: | 1/12/2018 |
| Start Date: | December 2010 |
| End Date: | February 2012 |
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.
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.
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.
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
We found this trial at
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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