Phase 3 N=80 Randomized Quadruple-blind Treatment

Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Hyperlipidemia · Blood Pressure · Oxidative Stress

Bottom Line

View on ClinicalTrials.gov: NCT01267227 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: LDL — 19.67; 20.04; 5.33; 0 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pterostilbene 50 mg twice daily (Drug); Placebo (Drug); Grape Extract (Drug); Pterostilbene 125 mg twice daily (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Mississippi Medical Center
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY LDL	19.67; 20.04; 5.33; 0	—
SECONDARY Blood Pressure	7.77; 3.67; 6.72; 0	—
SECONDARY Subjective Adverse Effects	5; 3; 2; 2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01267227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.