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J Toxicol. 2013;2013:463595. doi: 10.1155/2013/463595. Epub 2013 Feb 4.

Analysis of safety from a human clinical trial with pterostilbene.

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1
Department of Pharmacy Practice, The University of Mississippi School of Pharmacy, 2500 North State Street, Jackson, MS 39216, USA ; Department of Medicine, The University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA.

Abstract

OBJECTIVES:

The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans.

METHODOLOGY:

The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily, (2) pterostilbene 50 mg twice daily, (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily, and (4) matching placebo twice daily for 6-8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects.

RESULTS:

The majority of patients completed the trial (91.3%). The average age was 54 years. The majority of patients were females (71%) and Caucasians (70%). There were no adverse drug reactions (ADRs) on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs.

CONCLUSION:

Pterostilbene is generally safe for use in humans up to 250 mg/day.

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