Analysis of safety from a human clinical trial with pterostilbene

Daniel M. Riche, Corey L. McEwen, Krista D. Riche, Justin J. Sherman, Marion R. Wofford, David Deschamp, Michael Griswold

Research output: Contribution to journalArticle

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.

LanguageEnglish (US)
Article number463595
JournalJournal of Toxicology
Volume2013
DOIs
StatePublished - 2013
Externally publishedYes

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Clinical Trials
Safety
Drug-Related Side Effects and Adverse Reactions
Placebos
Vitis
Hypercholesterolemia
Pharmaceutical Preparations
LDL Cholesterol
Linear Models
Biomarkers
Cholesterol
pterostilbene
Kidney
Glucose
Liver
Therapeutics

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology

Cite this

Riche, D. M., McEwen, C. L., Riche, K. D., Sherman, J. J., Wofford, M. R., Deschamp, D., & Griswold, M. (2013). Analysis of safety from a human clinical trial with pterostilbene. Journal of Toxicology, 2013, [463595]. DOI: 10.1155/2013/463595

Analysis of safety from a human clinical trial with pterostilbene. / Riche, Daniel M.; McEwen, Corey L.; Riche, Krista D.; Sherman, Justin J.; Wofford, Marion R.; Deschamp, David; Griswold, Michael.

In: Journal of Toxicology, Vol. 2013, 463595, 2013.

Research output: Contribution to journalArticle

Riche, DM, McEwen, CL, Riche, KD, Sherman, JJ, Wofford, MR, Deschamp, D & Griswold, M 2013, 'Analysis of safety from a human clinical trial with pterostilbene' Journal of Toxicology, vol. 2013, 463595. DOI: 10.1155/2013/463595
Riche DM, McEwen CL, Riche KD, Sherman JJ, Wofford MR, Deschamp D et al. Analysis of safety from a human clinical trial with pterostilbene. Journal of Toxicology. 2013;2013. 463595. Available from, DOI: 10.1155/2013/463595
Riche, Daniel M. ; McEwen, Corey L. ; Riche, Krista D. ; Sherman, Justin J. ; Wofford, Marion R. ; Deschamp, David ; Griswold, Michael. / Analysis of safety from a human clinical trial with pterostilbene. In: Journal of Toxicology. 2013 ; Vol. 2013.
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