Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

NCT01267227 | Completed Phase 2 Results

• 1 other identifier: 2010-0225
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Blood Pressure; Oxidative Stress

Keywords

Hyperlipidemia; Cholesterol; Blood Pressure; Oxidative Stress; Pterostilbene; Blueberry; Grape Extract

Outcome Measures

Primary Outcomes (1)

• LDL

  Increase in low density lipoprotein (LDL)

  Baseline and 6-8 weeks

Secondary Outcomes (2)

• Blood Pressure

  6-8 weeks

• Subjective Adverse Effects

  Baseline and 6-8 weeks

Study Arms (4)

High Dose

ACTIVE COMPARATOR

Pterostilbene 125 mg twice daily

Drug: Pterostilbene 125 mg twice daily

Low Dose

ACTIVE COMPARATOR

Pterostilbene 50 mg twice daily

Drug: Pterostilbene 50 mg twice daily

Low Dose Combination

ACTIVE COMPARATOR

Pterostilbene 50 mg/Grape Extract 100 mg twice daily

Drug: Pterostilbene 50 mg twice daily; Drug: Grape Extract

Placebo

PLACEBO COMPARATOR

Matching placebo twice daily

Drug: Placebo

Interventions

Pterostilbene 50 mg twice daily DRUG

Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks

Also known as: pTeroPure

Low Dose; Low Dose Combination

Placebo DRUG

Matching placebo by mouth twice daily for 6 to 8 weeks

Placebo

Grape Extract DRUG

Grape extract 100 mg twice daily for 6-8 weeks

Also known as: ShanStar Concord Grape

Low Dose Combination

Pterostilbene 125 mg twice daily DRUG

Pterostilbene 125 mg twice daily for 6-8 weeks

Also known as: pTeropure

High Dose

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (7)

• 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.

  PMID: 19549798 BACKGROUND

• 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.

  PMID: 15264904 BACKGROUND

• 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.

  PMID: 15853379 BACKGROUND

• 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.

  PMID: 17132211 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25057276 RESULT

• 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.

  PMID: 23431291 RESULT

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Pterocarpus marsupium; whole grape extract

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Daniel Riche
• Organization: University of Mississippi

driche@umc.edu

601-984-2640

Study Officials

• Daniel M Riche, Pharm.D.

  University of Mississsippi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pharmacy Practice and Medicine

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 28, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 10, 2018
• Results First Posted: May 3, 2013

Record last verified: 2017-12

Locations

US (1)