Blood Pressure, Hyperlipidemia, Oxidative Stress
Conditions
Keywords
Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract
Brief summary
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.
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.
Interventions
DRUGPterostilbene 50 mg twice daily
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
DRUGPlacebo
Matching placebo by mouth twice daily for 6 to 8 weeks
DRUGGrape Extract
Grape extract 100 mg twice daily for 6-8 weeks
DRUGPterostilbene 125 mg twice daily
Pterostilbene 125 mg twice daily for 6-8 weeks
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL | Baseline and 6-8 weeks | Increase in low density lipoprotein (LDL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 6-8 weeks | Reduction in systolic blood pressure versus placebo |
| Subjective Adverse Effects | Baseline and 6-8 weeks | Number of participants with adverse effects as a measure of safety |
Countries
United States
Participant flow
Recruitment details
Medical clinic
Participants by arm
| Arm | Count |
|---|---|
| High Dose Pterostilbene 125 mg twice daily | 20 |
| Low Dose Pterostilbene 50 mg twice daily | 20 |
| Low Dose Combination Pterostilbene 50 mg/Grape Extract 100 mg twice daily | 20 |
| Placebo Matching placebo twice daily | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | High Dose | Low Dose | Low Dose Combination | Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 16 Participants | 19 Participants | 17 Participants | 17 Participants |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 11.2 | 53.6 years STANDARD_DEVIATION 11.2 | 53.6 years STANDARD_DEVIATION 7.9 | 53.0 years STANDARD_DEVIATION 13.7 | 54.4 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 80 participants | 20 participants | 20 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 57 Participants | 14 Participants | 15 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Male | 23 Participants | 6 Participants | 5 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 20 | 3 / 20 | 2 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
LDL
Increase in low density lipoprotein (LDL)
Time frame: Baseline and 6-8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Dose | LDL | 19.67 mg/dL |
| Low Dose | LDL | 20.04 mg/dL |
| Low Dose Combination | LDL | 5.33 mg/dL |
| Placebo | LDL | 0 mg/dL |
Secondary
Blood Pressure
Reduction in systolic blood pressure versus placebo
Time frame: 6-8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Dose | Blood Pressure | 7.77 mmHg |
| Low Dose | Blood Pressure | 3.67 mmHg |
| Low Dose Combination | Blood Pressure | 6.72 mmHg |
| Placebo | Blood Pressure | 0 mmHg |
Secondary
Subjective Adverse Effects
Number of participants with adverse effects as a measure of safety
Time frame: Baseline and 6-8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose | Subjective Adverse Effects | 5 participants |
| Low Dose | Subjective Adverse Effects | 3 participants |
| Low Dose Combination | Subjective Adverse Effects | 2 participants |
| Placebo | Subjective Adverse Effects | 2 participants |