Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Primary Purpose
Hyperlipidemia, Blood Pressure, Oxidative Stress
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pterostilbene 50 mg twice daily
Placebo
Grape Extract
Pterostilbene 125 mg twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract
Eligibility Criteria
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
Sites / Locations
- University of Mississippi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
High Dose
Low Dose
Low Dose Combination
Placebo
Arm Description
Pterostilbene 125 mg twice daily
Pterostilbene 50 mg twice daily
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Matching placebo twice daily
Outcomes
Primary Outcome Measures
LDL
Increase in low density lipoprotein (LDL)
Secondary Outcome Measures
Blood Pressure
Reduction in systolic blood pressure versus placebo
Subjective Adverse Effects
Number of participants with adverse effects as a measure of safety
Full Information
NCT ID
NCT01267227
First Posted
December 17, 2010
Last Updated
December 11, 2017
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01267227
Brief Title
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Official Title
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Blood Pressure, Oxidative Stress
Keywords
Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose
Arm Type
Active Comparator
Arm Description
Pterostilbene 125 mg twice daily
Arm Title
Low Dose
Arm Type
Active Comparator
Arm Description
Pterostilbene 50 mg twice daily
Arm Title
Low Dose Combination
Arm Type
Active Comparator
Arm Description
Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Pterostilbene 50 mg twice daily
Other Intervention Name(s)
pTeroPure
Intervention Description
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo by mouth twice daily for 6 to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Grape Extract
Other Intervention Name(s)
ShanStar Concord Grape
Intervention Description
Grape extract 100 mg twice daily for 6-8 weeks
Intervention Type
Drug
Intervention Name(s)
Pterostilbene 125 mg twice daily
Other Intervention Name(s)
pTeropure
Intervention Description
Pterostilbene 125 mg twice daily for 6-8 weeks
Primary Outcome Measure Information:
Title
LDL
Description
Increase in low density lipoprotein (LDL)
Time Frame
Baseline and 6-8 weeks
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Reduction in systolic blood pressure versus placebo
Time Frame
6-8 weeks
Title
Subjective Adverse Effects
Description
Number of participants with adverse effects as a measure of safety
Time Frame
Baseline and 6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Riche, Pharm.D.
Organizational Affiliation
University of Mississsippi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19549798
Citation
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.
Results Reference
background
PubMed Identifier
15264904
Citation
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.
Results Reference
background
PubMed Identifier
15853379
Citation
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.
Results Reference
background
PubMed Identifier
17132211
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25057276
Citation
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.
Results Reference
result
PubMed Identifier
23431291
Citation
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.
Results Reference
result
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Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
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