Analysis of Safety from a Human Clinical Trial with Pterostilbene

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 >= 200mg/dL and/or baseline low-density lipoprotein cholesterol = 100mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125mg twice daily, (2) pterostilbene 50mg twice daily, (3) pterostilbene 50mg + grape extract (GE) 100mg 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 250mg/day.