Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Blood Pressure Clinical Trial

Official title:

Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267227
• Other study ID #: 2010-0225
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 17, 2010
• Last updated: December 11, 2017
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2017
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Oxidative Stress

Intervention

Drug:
• Pterostilbene 50 mg twice daily
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
• Placebo
Matching placebo by mouth twice daily for 6 to 8 weeks
• Grape Extract
Grape extract 100 mg twice daily for 6-8 weeks
• Pterostilbene 125 mg twice daily
Pterostilbene 125 mg twice daily for 6-8 weeks

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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: 10.1155/2014/459 — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL	Increase in low density lipoprotein (LDL)	Baseline and 6-8 weeks
Secondary	Blood Pressure	Reduction in systolic blood pressure versus placebo	6-8 weeks
Secondary	Subjective Adverse Effects	Number of participants with adverse effects as a measure of safety	Baseline and 6-8 weeks