title: Clinical safety assessment of oral higenamine supplementation in healthy, young men.
abstract: OBJECTIVE
  Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents.
  
  
  METHODS
  Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel.
  
  
  RESULTS
  No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05).
  
  
  CONCLUSIONS
  This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings.
authors.affiliation: Cardiorespiratory/Metabolic Laboratory, Department of Health and Sport Sciences, The University of Memphis, Memphis, Tennessee, USA rbloomer@memphis.edu.
authors.forename: R J
authors.initials: RJ
authors.lastname: Bloomer
authors.affiliation: Cardiorespiratory/Metabolic Laboratory, Department of Health and Sport Sciences, The University of Memphis, Memphis, Tennessee, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Schriefer
authors.affiliation: Cardiorespiratory/Metabolic Laboratory, Department of Health and Sport Sciences, The University of Memphis, Memphis, Tennessee, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Gunnels
mesh_terms: D000284:Administration, Oral; D000318:Adrenergic beta-Agonists / Q000494:pharmacology; D000328:Adult; D000470:Alkaloids / Q000494:pharmacology*; D001794:Blood Pressure / Q000187:drug effects; D002110:Caffeine / Q000494:pharmacology*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004347:Drug Interactions; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008066:Lipolysis; D008297:Male; D024301:Plant Bark; D010936:Plant Extracts / Q000494:pharmacology*; D044005:Tetrahydroisoquinolines / Q000494:pharmacology*; D015016:Yohimbine; D055815:Young Adult
chemical_list: D000318:Adrenergic beta-Agonists; D000470:Alkaloids; D010936:Plant Extracts; D044005:Tetrahydroisoquinolines; D015016:Yohimbine; D002110:Caffeine; C012348:higenamine
keywords: Higenamine; caffeine; dietary supplements; norcoclaurine; safety