title: Analysis of safety from a human clinical trial with pterostilbene.
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.
authors: 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.
authors: Daniel M
authors: DM
authors: Riche
authors: Corey L
authors: CL
authors: McEwen
authors: Krista D
authors: KD
authors: Riche
authors: Justin J
authors: JJ
authors: Sherman
authors: Marion R
authors: MR
authors: Wofford
authors: David
authors: D
authors: Deschamp
authors: Michael
authors: M
authors: Griswold